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Lansoprazole Delayed Release Orally Disintegrating Tablets,116 15 Mg 45 14 5 Proposed Draft Labeling 4188168 ID: Reference 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 Batch No. 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. 15 5 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 HAIRLINES: 0.5 pt 5-16-17 Proposed Draft Labeling 4188168 ID: Reference 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 Batch No. 8U174 FA C5 8U174 FA 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. distributor of Inc., Novartis Consumer Health, *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.
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