45

45 14 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets,116 15 mg

14 Tablets (Inner Carton)

14.5

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

you develop a rash or joint pain joint or rash a develop you diarrhea get you

I I

polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you

I 8U174 00 V5 EXP No. Batch

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize you need to take this product for more than 14 days 14 than more for product this take to need you I

copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, Stop use and ask a doctor if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your I

Inactive ingredients Inactive ascorbic acid, cetyl alcohol, colloidal silicon dioxide, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

methotrexate (arthritis medicine) (arthritis methotrexate I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir

I

protect product from moisture from product protect

I

tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus

I

keep product out of high heat and humidity and heat high of out product keep (68-77°F) 20-25°C at store

I I

theophylline (asthma medicine) (asthma theophylline

I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep

I

digoxin (heart medicine) medicine) (heart digoxin

I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription I Other information Other

warfarin (blood-thinning medicine) (blood-thinning warfarin I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children

I

stomach pain pain stomach vomiting or nausea I

I CODE AREA

4 months unless directed by a doctor a by directed unless months 4 unexplained weight loss loss weight unexplained I

do not take for more than 14 days or more often than every every than often more or days 14 than more for take not do frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent

I I

chest pain chest frequent frequent you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you I I

spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

do not take this medicine with alcohol with medicine this take not do

I I lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had I

do not take more than 1 tablet a day a tablet 1 than more take not do

I liver disease liver I

take every day for 14 days 14 for day every take I Ask a doctor before use if you have you if use before doctor a Ask

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

See your doctor. your See place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

bloody or black stools. These may be signs of a serious condition. condition. serious a of signs be may These stools. black or bloody do not crush or chew tablets chew or crush not do

I

if you have trouble or pain swallowing food, vomiting with blood, or or blood, with vomiting food, swallowing pain or trouble have you if I take 1 tablet before eating in the morning the in eating before tablet 1 take I

Do not use not Do

14-Day Course of Treatment of Course 14-Day

Allergy alert: Allergy do not use if you are allergic to lansoprazole to allergic are you if use not do relief of symptoms within 24 hours 24 within symptoms of relief

Warnings

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I

1 to 4 days for full effect full for days 4 to 1

adults 18 years of age and older and age of years 18 adults

I

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not I

Directions

Use 2 or more or 2 days a week) a days (occurs heartburn frequent treats I

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

Purpose tablet) each (in ingredient Active If pregnant or breast-feeding, or pregnant If ask a health professional before use. before professional health a ask

Drug Facts Drug Drug Facts Facts Drug (continued)

Safety Feature – KEEP THE CARTON AND PACKAGE INSERT. Do not use if printed tablet THEY CONTAIN IMPORTANT INFORMATION. NOT FOR RESALE blister unit is open or torn. 55 15 Treats Frequent Heartburn

24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Acid Reducer Melts in your mouth Dissolves without water • May take 1 to 4 days for full effect

Strawberry Flavor One 14-day course

14 TABLETS of treatment Actual size

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

Questions or comments? or Questions 1-800-719-9260:

Manufactured by: Manufactured

Drug Facts Facts Drug (continued) Made in Israel in Made

MODIFIED FORMAT TYPE SIZES: TITLE: 8 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 7 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 7 pt Helvetica Neue 57 Condensed HEADINGS: 7 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6 pt BULLETS: 5 pt Square with 2 M'S spacing between statements TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed HEAVY LINES: 1.5 pt Reference ID: 4188168 HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

14 Tablets

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

you develop a rash or joint pain joint or rash a develop you diarrhea get you

I I

polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you

I E No. Batch 8U174 FA C5

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize X you need to take this product for more than 14 days 14 than more for product this take to need you I

P

copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, Stop use and ask a doctor if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your

Prevacid® 24 HR. Novartis Consumer Health, Inc., distributor of *This product is not manufactured or distributed by I

Inactive ingredients Inactive ascorbic acid, cetyl alcohol, colloidal silicon dioxide, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

methotrexate (arthritis medicine) (arthritis methotrexate I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir

I

protect product from moisture from product protect

I

tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus

I

keep product out of high heat and humidity and heat high of out product keep (68-77°F) 20-25°C at store

I I

theophylline (asthma medicine) (asthma theophylline

I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep

I

digoxin (heart medicine) medicine) (heart digoxin

I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription I Other information Other

warfarin (blood-thinning medicine) (blood-thinning warfarin I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children

I

stomach pain pain stomach vomiting or nausea I

I CODE AREA

4 months unless directed by a doctor a by directed unless months 4 unexplained weight loss loss weight unexplained I

do not take for more than 14 days or more often than every every than often more or days 14 than more for take not do frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent

I I

chest pain chest frequent frequent you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you I I

spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

do not take this medicine with alcohol with medicine this take not do

I I lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had I

do not take more than 1 tablet a day a tablet 1 than more take not do

I liver disease liver I

take every day for 14 days 14 for day every take I Ask a doctor before use if you have you if use before doctor a Ask

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

See your doctor. your See place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

bloody or black stools. These may be signs of a serious condition. condition. serious a of signs be may These stools. black or bloody do not crush or chew tablets chew or crush not do

I

if you have trouble or pain swallowing food, vomiting with blood, or or blood, with vomiting food, swallowing pain or trouble have you if I take 1 tablet before eating in the morning the in eating before tablet 1 take I

Do not use not Do

14-Day Course of Treatment of Course 14-Day

Allergy alert: Allergy do not use if you are allergic to lansoprazole to allergic are you if use not do relief of symptoms within 24 hours 24 within symptoms of relief

Warnings

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I

1 to 4 days for full effect full for days 4 to 1

adults 18 years of age and older and age of years 18 adults

I

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not I

Directions

Use 2 or more or 2 days a week) a days (occurs heartburn frequent treats I

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

Purpose tablet) each (in ingredient Active If pregnant or breast-feeding, or pregnant If ask a health professional before use. before professional health a ask

Drug Facts Drug Drug Facts Facts Drug (continued)

Safety Feature – KEEP THE CARTON AND PACKAGE INSERT. Do not use if printed tablet THEY CONTAIN IMPORTANT INFORMATION. blister unit is open or torn.

NDC 64239-181-01 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

ONE 14-DAY COURSE Melts in your mouth

14 TABLETS OF TREATMENT Dissolves without water Actual size

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

Questions or comments? or Questions 1-800-719-9260:

Manufactured by: Manufactured

Drug Facts Facts Drug (continued) Made in Israel in Made

MODIFIED FORMAT TYPE SIZES: TITLE: 8 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 7 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 7 pt Helvetica Neue 57 Condensed HEADINGS: 7 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6 pt BULLETS: 5 pt Square with 2 M'S spacing between statements TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed Reference ID: 4188168 HEAVY LINES: 1.5 pt HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

28 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I

you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you

I mg

unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats I Lansoprazole Delayed Release 15 Tablets Orally Disintegrating If pregnant or breast-feeding, or pregnant If ask a health professional before use. before professional health a ask

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your X I

8U130 FA C5 8U130 FA Batch No. E

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-02 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth TWO 14-DAY COURSES Dissolves without water Actual 28 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed Reference ID: 4188168 HEAVY LINES: 1.5 pt HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

42 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you I

mg unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats

I

If pregnant or breast-feeding, or pregnant If

ask a health professional before use. before professional health a ask Lansoprazole Delayed Release 15 Tablets Orally Disintegrating

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your

X I

Batch No. E 8U155 FA C5 8U155 FA

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg

Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-03 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth THREE 14-DAY COURSES Dissolves without water Actual 42 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed HEAVY LINES: 1.5 pt 5-16-17 Reference ID: 4188168 HAIRLINES: 0.5 pt Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

14 Tablets

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

you develop a rash or joint pain joint or rash a develop you diarrhea get you

I I

polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you

I E No. Batch 8U174 FA C5-V

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize X you need to take this product for more than 14 days 14 than more for product this take to need you I

P

copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, Stop use and ask a doctor if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your

Prevacid® 24 HR. Novartis Consumer Health, Inc., distributor of *This product is not manufactured or distributed by I

Inactive ingredients Inactive ascorbic acid, cetyl alcohol, colloidal silicon dioxide, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

methotrexate (arthritis medicine) (arthritis methotrexate I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir

I

protect product from moisture from product protect

I

tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus

I

keep product out of high heat and humidity and heat high of out product keep (68-77°F) 20-25°C at store

I I

theophylline (asthma medicine) (asthma theophylline

I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep

I

digoxin (heart medicine) medicine) (heart digoxin

I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription I Other information Other

warfarin (blood-thinning medicine) (blood-thinning warfarin I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children

I

stomach pain pain stomach vomiting or nausea I

I CODE AREA

4 months unless directed by a doctor a by directed unless months 4 unexplained weight loss loss weight unexplained I

do not take for more than 14 days or more often than every every than often more or days 14 than more for take not do frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent

I I

chest pain chest frequent frequent you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you I I

spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

do not take this medicine with alcohol with medicine this take not do

I I lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had I

do not take more than 1 tablet a day a tablet 1 than more take not do

I liver disease liver I

take every day for 14 days 14 for day every take I Ask a doctor before use if you have you if use before doctor a Ask

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

See your doctor. your See place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

bloody or black stools. These may be signs of a serious condition. condition. serious a of signs be may These stools. black or bloody do not crush or chew tablets chew or crush not do

I

if you have trouble or pain swallowing food, vomiting with blood, or or blood, with vomiting food, swallowing pain or trouble have you if I take 1 tablet before eating in the morning the in eating before tablet 1 take I

Do not use not Do

14-Day Course of Treatment of Course 14-Day

Allergy alert: Allergy do not use if you are allergic to lansoprazole to allergic are you if use not do relief of symptoms within 24 hours 24 within symptoms of relief

Warnings

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I

1 to 4 days for full effect full for days 4 to 1

adults 18 years of age and older and age of years 18 adults

I

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not I

Directions

Use 2 or more or 2 days a week) a days (occurs heartburn frequent treats I

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

Purpose tablet) each (in ingredient Active If pregnant or breast-feeding, or pregnant If ask a health professional before use. before professional health a ask

Drug Facts Drug Drug Facts Facts Drug (continued)

Safety Feature – KEEP THE CARTON AND PACKAGE INSERT. Do not use if printed tablet THEY CONTAIN IMPORTANT INFORMATION. blister unit is open or torn.

NDC 64239-181-01 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor

Acid Reducer Orally I May take 1 to 4 days for full effect Disintegrating Tablets

ONE 14-DAY COURSE Melts in your mouth

14 TABLETS OF TREATMENT Dissolves without water Actual size

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

Questions or comments? or Questions 1-800-719-9260:

Manufactured by: Manufactured

Drug Facts Facts Drug (continued) Made in Israel in Made

MODIFIED FORMAT TYPE SIZES: TITLE: 8 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 7 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 7 pt Helvetica Neue 57 Condensed HEADINGS: 7 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6 pt BULLETS: 5 pt Square with 2 M'S spacing between statements TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed Reference ID: 4188168 HEAVY LINES: 1.5 pt HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

28 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I

you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you

I mg

unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats I Lansoprazole Delayed Release 15 Tablets Orally Disintegrating If pregnant or breast-feeding, or pregnant If ask a health professional before use. before professional health a ask

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your X I

8U130 FA C5-V 8U130 FA Batch No. E

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-02 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor

Acid Reducer Orally I May take 1 to 4 days for full effect Disintegrating Tablets Melts in your mouth TWO 14-DAY COURSES Dissolves without water Actual 28 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed Reference ID: 4188168 HEAVY LINES: 1.5 pt HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

42 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you I

mg unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats

I

If pregnant or breast-feeding, or pregnant If

ask a health professional before use. before professional health a ask Lansoprazole Delayed Release 15 Tablets Orally Disintegrating

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your

X I

Batch No. E 8U155 FA C5-V 8U155 FA

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg

Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-03 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor

Acid Reducer Orally I May take 1 to 4 days for full effect Disintegrating Tablets Melts in your mouth THREE 14-DAY COURSES Dissolves without water Actual 42 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed HEAVY LINES: 1.5 pt 5-16-17 Reference ID: 4188168 HAIRLINES: 0.5 pt Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

14 Tablets

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

you develop a rash or joint pain joint or rash a develop you diarrhea get you

I I

polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you

I E No. Batch 8U174 FA C5-J

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize X you need to take this product for more than 14 days 14 than more for product this take to need you I

P

copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, Stop use and ask a doctor if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your

Prevacid® 24 HR. Novartis Consumer Health, Inc., distributor of *This product is not manufactured or distributed by I

Inactive ingredients Inactive ascorbic acid, cetyl alcohol, colloidal silicon dioxide, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

methotrexate (arthritis medicine) (arthritis methotrexate I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir

I

protect product from moisture from product protect

I

tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus

I

keep product out of high heat and humidity and heat high of out product keep (68-77°F) 20-25°C at store

I I

theophylline (asthma medicine) (asthma theophylline

I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep

I

digoxin (heart medicine) medicine) (heart digoxin

I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription I Other information Other

warfarin (blood-thinning medicine) (blood-thinning warfarin I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children

I

stomach pain pain stomach vomiting or nausea I

I CODE AREA

4 months unless directed by a doctor a by directed unless months 4 unexplained weight loss loss weight unexplained I

do not take for more than 14 days or more often than every every than often more or days 14 than more for take not do frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent

I I

chest pain chest frequent frequent you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you I I

spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

do not take this medicine with alcohol with medicine this take not do

I I lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had I

do not take more than 1 tablet a day a tablet 1 than more take not do

I liver disease liver I

take every day for 14 days 14 for day every take I Ask a doctor before use if you have you if use before doctor a Ask

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

See your doctor. your See place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

bloody or black stools. These may be signs of a serious condition. condition. serious a of signs be may These stools. black or bloody do not crush or chew tablets chew or crush not do

I

if you have trouble or pain swallowing food, vomiting with blood, or or blood, with vomiting food, swallowing pain or trouble have you if I take 1 tablet before eating in the morning the in eating before tablet 1 take I

Do not use not Do

14-Day Course of Treatment of Course 14-Day

Allergy alert: Allergy do not use if you are allergic to lansoprazole to allergic are you if use not do relief of symptoms within 24 hours 24 within symptoms of relief

Warnings

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I

1 to 4 days for full effect full for days 4 to 1

adults 18 years of age and older and age of years 18 adults

I

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not I

Directions

Use 2 or more or 2 days a week) a days (occurs heartburn frequent treats I

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

Purpose tablet) each (in ingredient Active If pregnant or breast-feeding, or pregnant If ask a health professional before use. before professional health a ask

Drug Facts Drug Drug Facts Facts Drug (continued)

Safety Feature – KEEP THE CARTON AND PACKAGE INSERT. Do not use if printed tablet THEY CONTAIN IMPORTANT INFORMATION. blister unit is open or torn.

NDC 64239-181-01 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* 24 Hour Child-resistant Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

ONE 14-DAY COURSE Melts in your mouth

14 TABLETS OF TREATMENT Dissolves without water Actual size

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

Questions or comments? or Questions 1-800-719-9260:

Manufactured by: Manufactured

Drug Facts Facts Drug (continued) Made in Israel in Made

MODIFIED FORMAT TYPE SIZES: TITLE: 8 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 7 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 7 pt Helvetica Neue 57 Condensed HEADINGS: 7 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6 pt BULLETS: 5 pt Square with 2 M'S spacing between statements TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed Reference ID: 4188168 HEAVY LINES: 1.5 pt HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

28 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I

you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you

I mg

unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats I Lansoprazole Delayed Release 15 Tablets Orally Disintegrating If pregnant or breast-feeding, or pregnant If ask a health professional before use. before professional health a ask

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your X I

8U130 FA C5-J 8U130 FA Batch No. E

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-02 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* Child-resistant 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth TWO 14-DAY COURSES Dissolves without water Actual 28 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed HEAVY LINES: 1.5 pt Reference ID: 4188168 HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

42 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you I

mg unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats

I

If pregnant or breast-feeding, or pregnant If

ask a health professional before use. before professional health a ask Lansoprazole Delayed Release 15 Tablets Orally Disintegrating

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your

X I

Batch No. E 8U155 FA C5-J 8U155 FA

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg

Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-03 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* Child-resistant 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth THREE 14-DAY COURSES Dissolves without water Actual 42 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed HEAVY LINES: 1.5 pt 5-16-17 Reference ID: 4188168 HAIRLINES: 0.5 pt Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

28 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I

you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you

I mg

unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats I Lansoprazole Delayed Release 15 Tablets Orally Disintegrating If pregnant or breast-feeding, or pregnant If ask a health professional before use. before professional health a ask

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your X I

8U130 FA C5-A 8U130 FA Batch No. E

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-02 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* Value 2 Pack 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth TWO 14-DAY COURSES Dissolves without water Actual 28 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed HEAVY LINES: 1.5 pt Reference ID: 4188168 HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

42 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you I

mg unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats

I

If pregnant or breast-feeding, or pregnant If

ask a health professional before use. before professional health a ask Lansoprazole Delayed Release 15 Tablets Orally Disintegrating

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your

X I

Batch No. E 8U155 FA C5-B 8U155 FA

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg

Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-03 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* Value 3 Pack 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth THREE 14-DAY COURSES Dissolves without water Actual 42 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed HEAVY LINES: 1.5 pt 5-16-17 Reference ID: 4188168 HAIRLINES: 0.5 pt Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

28 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I

you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you

I mg

unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats I Lansoprazole Delayed Release 15 Tablets Orally Disintegrating If pregnant or breast-feeding, or pregnant If ask a health professional before use. before professional health a ask

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your X I

8U130 FA C5-K 8U130 FA Batch No. E

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-02 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* Buy One 14 Count, 24 Hour Get One 14 Count Free! Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth TWO 14-DAY COURSES Dissolves without water Actual 28 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed HEAVY LINES: 1.5 pt Reference ID: 4188168 HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

28 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I

you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you

I mg

unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats I Lansoprazole Delayed Release 15 Tablets Orally Disintegrating If pregnant or breast-feeding, or pregnant If ask a health professional before use. before professional health a ask

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your X I

8U130 FA C5-L 8U130 FA Batch No. E

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-02 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* 100% More Free! 24 Hour 14 Free Tablets! Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth TWO 14-DAY COURSES Dissolves without water Actual 28 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed Reference ID: 4188168 HEAVY LINES: 1.5 pt HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

28 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I

you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you

I mg

unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats I Lansoprazole Delayed Release 15 Tablets Orally Disintegrating If pregnant or breast-feeding, or pregnant If ask a health professional before use. before professional health a ask

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your X I

8U130 FA C5-N 8U130 FA Batch No. E

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-02 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* Bonus Size! 24 Hour 14 Tablets Free Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth TWO 14-DAY COURSES Dissolves without water Actual 28 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed Reference ID: 4188168 HEAVY LINES: 1.5 pt HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

28 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I

you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you

I mg

unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats I Lansoprazole Delayed Release 15 Tablets Orally Disintegrating If pregnant or breast-feeding, or pregnant If ask a health professional before use. before professional health a ask

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your X I

8U130 FA C5-P 8U130 FA Batch No. E

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-02 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* Bonus Size! 14 Free 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth TWO 14-DAY COURSES Dissolves without water Actual 28 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed Reference ID: 4188168 HEAVY LINES: 1.5 pt HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

28 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I

you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you

I mg

unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats I Lansoprazole Delayed Release 15 Tablets Orally Disintegrating If pregnant or breast-feeding, or pregnant If ask a health professional before use. before professional health a ask

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your X I

8U130 FA C5-R 8U130 FA Batch No. E

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-02 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* Bonus! + 14 Free 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth TWO 14-DAY COURSES Dissolves without water Actual 28 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed HEAVY LINES: 1.5 pt Reference ID: 4188168 HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

28 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I

you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you

I mg

unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats I Lansoprazole Delayed Release 15 Tablets Orally Disintegrating If pregnant or breast-feeding, or pregnant If ask a health professional before use. before professional health a ask

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your X I

8U130 FA C5-S 8U130 FA Batch No. E

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-02 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* Bonus! 14 Tablets FREE 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth TWO 14-DAY COURSES Dissolves without water Actual 28 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed HEAVY LINES: 1.5 pt Reference ID: 4188168 HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

42 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you I

mg unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats

I

If pregnant or breast-feeding, or pregnant If

ask a health professional before use. before professional health a ask Lansoprazole Delayed Release 15 Tablets Orally Disintegrating

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your

X I

Batch No. E 8U155 FA C5-M 8U155 FA

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg

Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-03 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* Bonus Pack: 28 + 14 Free 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth THREE 14-DAY COURSES Dissolves without water Actual 42 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed HEAVY LINES: 1.5 pt Reference ID: 4188168 HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

42 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you I

mg unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats

I

If pregnant or breast-feeding, or pregnant If

ask a health professional before use. before professional health a ask Lansoprazole Delayed Release 15 Tablets Orally Disintegrating

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your

X I

Batch No. E 8U155 FA C5-N 8U155 FA

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg

Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-03 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* Bonus Size! 24 Hour 14 Tablets Free Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth THREE 14-DAY COURSES Dissolves without water Actual 42 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed HEAVY LINES: 1.5 pt 5-16-17 Reference ID: 4188168 HAIRLINES: 0.5 pt Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

42 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you I

mg unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats

I

If pregnant or breast-feeding, or pregnant If

ask a health professional before use. before professional health a ask Lansoprazole Delayed Release 15 Tablets Orally Disintegrating

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your

X I

Batch No. E 8U155 FA C5-P 8U155 FA

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg

Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-03 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* Bonus Size! 14 Free 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth THREE 14-DAY COURSES Dissolves without water Actual 42 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed HEAVY LINES: 1.5 pt 5-16-17 Reference ID: 4188168 HAIRLINES: 0.5 pt Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

42 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you I

mg unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats

I

If pregnant or breast-feeding, or pregnant If

ask a health professional before use. before professional health a ask Lansoprazole Delayed Release 15 Tablets Orally Disintegrating

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your

X I

Batch No. E 8U155 FA C5-R 8U155 FA

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg

Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-03 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* Bonus! + 14 Free 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth THREE 14-DAY COURSES Dissolves without water Actual 42 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed HEAVY LINES: 1.5 pt 5-16-17 Reference ID: 4188168 HAIRLINES: 0.5 pt Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg

42 Tablets

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Prevacid® 24 HR. 24 Prevacid® of distributor Inc., Health, Consumer Novartis by distributed or manufactured not is product *This

10 Hakidma Street, Yokneam 2069200, Israel 2069200, Yokneam Street, Hakidma 10

Manufactured by: Manufactured

Made in Israel in Made

Questions or comments? comments? or Questions 1-800-719-9260: weekdays 7:30 AM to 5:00 PM EST PM 5:00 to AM 7:30 weekdays

sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate triethyl dioxide, titanium talc, spheres, sugar sucralose, sorbitol,

maize maltodextrin, maltitol, mannitol, meglumine, microcrystalline cellulose, polysorbate 80, propylene glycol, silicon dioxide, sodium stearyl fumarate, fumarate, stearyl sodium dioxide, silicon glycol, propylene 80, polysorbate cellulose, microcrystalline meglumine, mannitol, maltitol, maltodextrin, maize

Inactive ingredients Inactive

ascorbic acid, cetyl alcohol, colloidal silicon dioxide, copovidone, crospovidone, flavor, hypromellose, hypromellose phthalate, phthalate, hypromellose hypromellose, flavor, crospovidone, copovidone, dioxide, silicon colloidal alcohol, cetyl acid, ascorbic

Drug Facts Facts Drug (continued)

methotrexate (arthritis medicine) (arthritis methotrexate protect product from moisture from product protect I I I

atazanavir (medicine for HIV infection) HIV for (medicine atazanavir keep product out of high heat and humidity humidity and heat high of out product keep (68-77°F) 20-25°C at store I I I

keep the carton and package insert. They contain important information. important contain They insert. package and carton the keep tacrolimus or mycophenolate mofetil (immune system medicines) system (immune mofetil mycophenolate or tacrolimus I I

read the directions, warnings and package insert before use use before insert package and warnings directions, the read theophylline (asthma medicine) (asthma theophylline I I

Other information Other digoxin (heart medicine) medicine) (heart digoxin I

prescription antifungal or anti-yeast medicines anti-yeast or antifungal prescription

I

children may sometimes be caused by a serious condition. serious a by caused be sometimes may children

warfarin (blood-thinning medicine) (blood-thinning warfarin I

children under 18 years of age: ask a doctor before use. Heartburn in in Heartburn use. before doctor a ask age: of years 18 under children I

Ask a doctor or pharmacist before use if you are taking are you if use before pharmacist or doctor a Ask

unless directed by a doctor a by directed unless

stomach pain pain stomach

I do not take for more than 14 days or more often than every 4 months months 4 every than often more or days 14 than more for take not do

I

nausea or vomiting vomiting or nausea I you may repeat a 14-day course every 4 months 4 every course 14-day a repeat may you I

mg unexplained weight loss loss weight unexplained I

Repeated 14-Day Course (if needed) (if Course 14-Day Repeated

frequent wheezing, particularly with heartburn heartburn with particularly wheezing, frequent I

do not take this medicine with alcohol with medicine this take not do

I I chest pain chest frequent frequent I

do not use for more than 14 days unless directed by your doctor your by directed unless days 14 than more for use not do

I spreading to arms, neck or shoulders; or lightheadedness lightheadedness or shoulders; or neck arms, to spreading

do not take more than 1 tablet a day a tablet 1 than more take not do I

chest pain or shoulder pain with shortness of breath; sweating; pain pain sweating; breath; of shortness with pain shoulder or pain chest I

take every day for 14 days 14 for day every take I

lightheadedness, sweating or dizziness or sweating lightheadedness, heartburn with with heartburn I

The tablets can also be swallowed whole with water. with whole swallowed be also can tablets The

had heartburn over 3 months. This may be a sign of a more serious condition. serious more a of sign a be may This months. 3 over heartburn had

I

place the tablet on tongue; tablet disintegrates, with or without water. water. without or with disintegrates, tablet tongue; on tablet the place I

liver disease liver I

do not crush or chew tablets chew or crush not do

I

Ask a doctor before use if you have have you if use before doctor a Ask

take 1 tablet before eating in the morning the in eating before tablet 1 take I

black stools. These may be signs of a serious condition. See your doctor. your See condition. serious a of signs be may These stools. black 14-Day Course of Treatment of Course 14-Day

bloody or or bloody or blood, with vomiting food, swallowing pain or trouble have you f i I

relief of symptoms within 24 hours 24 within symptoms of relief

Do not use not Do

it may take 1 to 4 days for full effect, although some people get complete complete get people some although effect, full for days 4 to 1 take may it I

CODE AREA

this product is to be used once a day (every 24 hours), every day for 14 days 14 for day every hours), 24 (every day a once used be to is product this I Allergy alert: Allergy

do not use if you are allergic to lansoprazole to allergic are you if use not do

adults 18 years of age and older and age of years 18 adults I Warnings

Directions

1 to 4 days for full effect full for days 4 to 1

contact a Poison Control Center right away (1-800-222-1222). away right Center Control Poison a contact

not intended for immediate relief of heartburn; this drug may take take may drug this heartburn; of relief immediate for intended not

I Keep out of reach of children. of reach of out Keep In case of overdose, get medical help or or help medical get overdose, of case In

2 or more or 2 days a week) a days (occurs heartburn frequent treats

I

If pregnant or breast-feeding, or pregnant If

ask a health professional before use. before professional health a ask Lansoprazole Delayed Release 15 Tablets Orally Disintegrating

Use

you develop a rash or joint pain pain joint or rash a develop you diarrhea get you I I

you need to take more than 1 course of treatment every 4 months 4 every treatment of course 1 than more take to need you I

Lansoprazole 15 mg...... Acid Reducer mg...... Acid 15 Lansoprazole

you need to take this product for more than 14 days 14 than more for product this take to need you I

P Purpose tablet) each (in ingredient Active

Stop use and ask a doctor if if doctor a ask and use Stop your heartburn continues or worsens or continues heartburn your

X I

Batch No. E 8U155 FA C5-S 8U155 FA

Drug Facts Drug Drug Facts Facts Drug (continued)

Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg

Safety Feature – Do not use if printed tablet blister unit is open or torn.

KEEP THE CARTON AND PACKAGE INSERT. THEY CONTAIN IMPORTANT INFORMATION.

NDC 64239-181-03 Treats Frequent Heartburn Compare to the active ingredient New Dosage Form! in Prevacid® 24 HR* Bonus! 14 Tablets FREE 24 Hour Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg Strawberry Flavor Acid Reducer I May take 1 to 4 days for full effect

Melts in your mouth THREE 14-DAY COURSES Dissolves without water Actual 42 TABLETS OF TREATMENT size

STANDARD FORMAT TYPE SIZES: TITLE: 9 pt Helvetica Neue 77 Bold Condensed Oblique TITLE (continued): 8 pt Helvetica Neue 77 Bold Condensed Oblique (continued) 8 pt Helvetica Neue 57 Condensed HEADINGS: 8 pt Helvetica Neue 77 Bold Condensed Oblique SUBHEADINGS: 6 pt Helvetica Neue 77 Bold Condensed TEXT: 6 pt Helvetica Neue 57 Condensed LEADING: 6.5 and 6.8 pt BULLETS: 5 pt Square TELEPHONE #: 6 pt Helvetica Neue 77 Bold Condensed HEAVY LINES: 1.5 pt 5-16-17 Reference ID: 4188168 HAIRLINES: 0.5 pt Proposed Draft Labeling NDA 208025 Lansoprazole Delayed Release Orally Disintegrating Tablets, 15 mg Package Insert

Front

Treats Frequent Heartburn Lansoprazole Delayed Release Orally Disintegrating Tablets 15 mg acid reducer

I May take 1 to 4 days for full effect

Please read the entire package insert before taking Lansoprazole Delayed Release Orally Disintegrating Tablets. Save for future reference.

How Lansoprazole delayed release Who Should NOT Take Lansoprazole orally disintegrating tablets Treats delayed release orally Your Frequent Heartburn disintegrating tablets Lansoprazole delayed release orally People who have one episode of heartburn disintegrating tablets stops acid production a week or less, or who want immediate at the source – the pumps that release acid relief of heartburn. into the stomach. Lansoprazole delayed release orally disintegrating tablets is taken How to Take Lansoprazole delayed once a day (every 24 hours), every day for release orally disintegrating tablets 14 days. 14-DAY Course of Treatment I Take 1 tablet before eating in the morning. What You Can Expect When Taking I Do not crush or chew tablets. Lansoprazole delayed release orally I Place the tablet on tongue; tablet disintegrating tablets disintegrates, with or without water. Frequent heartburn can occur anytime The tablets can also be swallowed whole during the 24-hour period (day or night). with water. Take Lansoprazole delayed release orally I Take every day for 14 days. disintegrating tablets in the morning before I Do not take more than 1 tablet a day. eating. Lansoprazole is clinically proven to I Do not use for more than 14 days unless treat frequent heartburn. Although some directed by your doctor. people get complete relief of symptoms I Do not take this medicine with alcohol. within 24 hours, it may take 1 to 4 days for full effect. Make sure you take Lansoprazole When to Take Lansoprazole delayed release orally disintegrating tablets delayed release orally every day for 14 days to treat your frequent disintegrating tablets Again heartburn. You may repeat a 14-day course of therapy every 4 months. Who Should Take Lansoprazole delayed release orally When to Talk to Your Doctor disintegrating tablets Do not take for more than 14 days or more Adults (18 years and older) with frequent often than every 4 months unless directed heartburn – when you have heartburn 2 or by a doctor. more days a week.

Reference ID: 4188168 5-30-17 Back

Warnings and When to Ask Tips for Managing Heartburn Your Doctor I Avoid foods or drinks that are more likely to Allergy alert: Do not use if you are allergic cause heartburn, such as rich, spicy, fatty to lansoprazole and fried foods, chocolate, caffeine, alcohol Do not use and even some acidic fruits and vegetables. I I if you have trouble or pain swallowing Eat slowly and do not eat big meals. food, vomiting with blood, or bloody or I Do not eat late at night or just before black stools. These may be signs of a bedtime. serious condition. See your doctor. I Do not lie flat or bend over soon after eating. I Raise the head of your bed. Ask a doctor before use if you have I Wear loose-fitting clothing around your I liver disease stomach. I had heartburn over 3 months. This may be I If you are overweight, lose weight. a sign of a more serious condition. I If you smoke, quit smoking. I heartburn with lightheadedness, sweating or dizziness Clinical studies prove I chest pain or shoulder pain with shortness lansoprazole effectively treats of breath; sweating; pain spreading to arms, frequent heartburn neck or shoulders; or lightheadedness In three clinical studies, lansoprazole was I frequent chest pain shown to be significantly better than placebo I frequent wheezing, particularly with in treating frequent heartburn. heartburn I unexplained weight loss How Lansoprazole delayed release I nausea or vomiting orally disintegrating tablets is Sold I stomach pain This medicine is available in 14 tablet, Ask a doctor or pharmacist before use if 28 tablet and 42 tablet sizes. These sizes you are taking contain one, two and three 14-day courses of I warfarin (blood-thinning medicine) treatment, respectively. Do not use for more I prescription antifungal or anti-yeast than 14 days in a row unless directed by your medicines doctor. For the 28 count (two 14-day courses) I digoxin (heart medicine) and the 42 count (three 14-day courses), you I theophylline (asthma medicine) may repeat a 14-day course every 4 months. I tacrolimus or mycophenolate mofetil (immune system medicines) For Questions or Comments About I atazanavir (medicine for HIV infection) Lansoprazole delayed release orally I methotrexate (arthritis medicine) disintegrating tablets Stop use and ask a doctor if Call 1-800-719-9260 I your heartburn continues or worsens weekdays 7:30 AM to 5:00 PM EST I you need to take this product for more than 14 days I you need to take more than 1 course of treatment every 4 months I you get diarrhea I you develop a rash or joint pain If pregnant or breast-feeding, ask a health professional before use. Made in Israel Keep out of reach of children. In case of Manufactured by: overdose, get medical help or contact a Poison Control Center right away 10 Hakidma Street, Yokneam 2069200, Israel (1-800-222-1222). : 8U100 00 J2

Reference ID: 4188168 5-30-17