Reference ID: 4727725 Matrix Code Scan Quality

401614688_FDASubmissionArt_Motrin_IB_24ct_Label_R2.pdf 1 10/3/19 11:55 AM

Do not use if foil inner seal imprinted “Sealed I toothache I backache I the common cold I menstrual cramps I temporarily reduces fever. Warnings: Allergy alert: Ibuprofen may cause a severe For Your Safety” is broken or missing allergic reaction, especially in people allergic to aspirin. Symptoms may include: I hives I facial swelling I asthma (wheezing) I shock I skin reddening NDC 50580-486-03 I rash I blisters. If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, ® which may cause severe stomach bleeding. The chance is higher if you: I are age 60 or older I have had stomach ulcers or bleeding problems I take a

00000000 blood thinning (anticoagulant) or steroid drug I take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] I have 3 or more alcoholic drinks every day while using this product I take more or for a longer time than directed. Heart attack and stroke warning: LOT: EXP. NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for Ibuprofen Tablets USP, 200 mg longer than directed. Do not use I if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer I right before or after heart Pain Reliever/Fever Reducer (NSAID) surgery. Stop use and ask a doctor if I you experience any of the following signs of stomach bleeding: I feel faint I vomit blood I have bloody or black stools I have stomach pain that does not get better. I you have symptoms of heart problems or stroke: I chest pain I trouble breathing I weakness in one 24 Coated Caplets* *Capsule-Shaped Tablets part or side of body I slurred speech I leg swelling. I pain gets worse or lasts more than 10 days I fever gets worse or lasts more than 3 days I redness or Important: Read all product information before using. swelling is present in the painful area I any new symptoms appear. If pregnant or breast-feeding, ask a health professional before use. Keep out of Keep the box for important information. reach of children. Directions I do not take more than directed I the smallest effective dose should be used. Adults and children 12 years and older: I take 1 caplet every 4 to 6 hours while symptoms persist I if pain or fever does not respond to 1 caplet, 2 caplets may be used I do not exceed Active ingredient (in each caplet) Purposes 6 caplets in 24 hours, unless directed by a doctor. Children under 12 years: I ask a doctor. Other information I store between 20-25°C (68-77°F) Ibuprofen 200 mg (NSAID)*...... Pain reliever/fever reducer Inactive ingredients carnauba wax, colloidal silicon dioxide, FD&C yellow no. 6 aluminum lake, hypromellose, iron oxide, magnesium stearate, modified *nonsteroidal anti-inflammatory drug starch, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, stearic acid, titanium dioxide Uses I temporarily relieves minor aches and pains due to: Distributed by: JOHNSON & JOHNSON CONSUMER INC., McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA I headache I muscular aches I minor pain of arthritis ©J&JCI 20XX www.motrin.com

HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic NA 4.50 3.50 80% 4.50 4.50 NA 4.50 NA NA -16

18211 NE 68th Street, E120 Redmond, WA 98052 T: 425-881-5454

File Name 401614688_FDASubmissionArt_Motrin_IB_24ct_Label_R2 Product Name MOTRIN IB Coated Caplets

Date 03OCT2019 McNeil Part No. NA Prepress Separator SGK Schawk Redmond Component Type Label Master PID No. NA Prepress Job No. 401614688 EM Part No. NA Comp. PID No. NA Artwork Program Adobe Illustrator CC 2017 Dieline No. LB-PS-1470 v2 Pharma Code NA

ARTWORK SPECIFICS Fonts HelveticaDF-Bold, CondMedium, CondBold, CondBoldItalic; Dialog Cond Italic, BoldItalic; ITC Zapf Dingbats; Arial-Regular; Myriad Pro-Regular PANTONE PANTONE Yellow Black 1655 C 2765 C

Do not use if foil inner seal imprinted “Sealed I toothache I backache I the common cold I menstrual cramps I temporarily reduces fever. Warnings: Allergy alert: Ibuprofen may cause a severe For Your Safety” is broken or missing allergic reaction, especially in people allergic to aspirin. Symptoms may include: I hives I facial swelling I asthma (wheezing) I shock I skin reddening NDC 50580-486-04 I rash I blisters. If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, ® which may cause severe stomach bleeding. The chance is higher if you: I are age 60 or older I have had stomach ulcers or bleeding problems I take a

00000000 blood thinning (anticoagulant) or steroid drug I take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] I have 3 or more alcoholic drinks every day while using this product I take more or for a longer time than directed. Heart attack and stroke warning: LOT: EXP. NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for Ibuprofen Tablets USP, 200 mg longer than directed. Do not use I if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer I right before or after heart Pain Reliever/Fever Reducer (NSAID) surgery. Stop use and ask a doctor if I you experience any of the following signs of stomach bleeding: I feel faint I vomit blood I have bloody or black stools I have stomach pain that does not get better. I you have symptoms of heart problems or stroke: I chest pain I trouble breathing I weakness in one 50 Coated Caplets* *Capsule-Shaped Tablets part or side of body I slurred speech I leg swelling. I pain gets worse or lasts more than 10 days I fever gets worse or lasts more than 3 days I redness or Important: Read all product information before using. swelling is present in the painful area I any new symptoms appear. If pregnant or breast-feeding, ask a health professional before use. Keep out of Keep the box for important information. reach of children. Directions I do not take more than directed I the smallest effective dose should be used. Adults and children 12 years and older: I take 1 caplet every 4 to 6 hours while symptoms persist I if pain or fever does not respond to 1 caplet, 2 caplets may be used I do not exceed Active ingredient (in each caplet) Purposes 6 caplets in 24 hours, unless directed by a doctor. Children under 12 years: I ask a doctor. Other information I store between 20-25°C (68-77°F) Ibuprofen 200 mg (NSAID)*...... Pain reliever/fever reducer Inactive ingredients carnauba wax, colloidal silicon dioxide, FD&C yellow no. 6 aluminum lake, hypromellose, iron oxide, magnesium stearate, modified *nonsteroidal anti-inflammatory drug starch, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, stearic acid, titanium dioxide Uses I temporarily relieves minor aches and pains due to: Distributed by: JOHNSON & JOHNSON CONSUMER INC., McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA I headache I muscular aches I minor pain of arthritis ©J&JCI 20XX www.motrin.com

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18211 NE 68th Street, E120 Redmond, WA 98052 T: 425-881-5454

File Name 401618095_FDASubmissionArt_Motrin_IB_50ct_Label_R2 Product Name MOTRIN IB Coated Caplets

Date 04OCT2019 McNeil Part No. NA Prepress Separator SGK Schawk Redmond Component Type Label Master PID No. NA Prepress Job No. 401618095 EM Part No. NA Comp. PID No. NA Artwork Program Adobe Illustrator CC 2017 Dieline No. LB-PS-1470 v2 Pharma Code NA

ARTWORK SPECIFICS Fonts HelveticaDF-Bold, CondMedium, CondBold, CondBoldItalic; Dialog Cond Italic, BoldItalic; ITC Zapf Dingbats; Arial-Regular PANTONE PANTONE Yellow Black 1655 C 2765 C

Do not use if foil inner seal imprinted “Sealed For Uses I temporarily relieves minor aches and pains due to: I headache I muscular aches I minor pain of arthritis I toothache I backache I the common cold Your Safety” is broken or missing I menstrual cramps I temporarily reduces fever. Warnings: Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.

NDC 50580-110-6 Symptoms may include: I hives I facial swelling I asthma (wheezing) I shock I skin reddening I rash I blisters. If an allergic reaction occurs, stop use and For Hospital and Government Use Only seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: I are age 60 or older I have had stomach ulcers or bleeding problems I take a blood thinning (anticoagulant) or steroid drug I take other drugs containing

00000000 NDC 50580-486-01 ® prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] I have 3 or more alcoholic drinks every day while using this product I take more or

LOT: EXP. for a longer time than directed. Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use I if you have ever had an allergic reaction to ibuprofen or any other pain Ibuprofen Tablets reliever/fever reducer I right before or after heart surgery. Stop use and ask a doctor if I you experience any of the following signs of stomach bleeding: I feel USP, 200 mg faint I vomit blood I have bloody or black stools I have stomach pain that does not get better. I you have symptoms of heart problems or stroke: I chest pain Pain Reliever 0 I trouble breathing I weakness in one part or side of body I slurred speech I leg swelling. I pain gets worse or lasts more than 10 days I fever gets worse or Fever Reducer (NSAID) lasts more than 3 days I redness or swelling is present in the painful area I any new symptoms appear. If pregnant or breast-feeding, ask a health professional *Capsule Coated before use. Keep out of reach of children. Directions I do not take more than directed I the smallest effective dose should be used. Adults and 60 Caplets* Shaped Tablets children 12 years and older: I take 1 caplet every 4 to 6 hours while symptoms persist I if pain or fever does not respond to 1 caplet, 2 caplets may be used Keep the box for important information. I do not exceed 6 caplets in 24 hours, unless directed by a doctor. Children under 12 years: I ask a doctor. Other information I store between 20-25°C (68-77°F). Inactive ingredients carnauba wax, colloidal silicon dioxide, FD&C yellow no. 6 aluminum lake, hypromellose, iron oxide, magnesium stearate, modified starch, Active ingredient (in each caplet) Purposes polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, stearic acid, titanium dioxide Ibuprofen 200 mg (NSAID)*...... Pain reliever/fever reducer Distributed by: JOHNSON & JOHNSON CONSUMER INC., McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA *nonsteroidal anti-inflammatory drug ©J&JCI 20XX www.motrin.com

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18211 NE 68th Street, E120 Redmond, WA 98052 T: 425-881-5454

File Name 401616509_FDASubmissionArt_Motrin_IB_HG_60ct_Label_R2 Product Name MOTRIN IB Coated Caplets

Date 02OCT2019 McNeil Part No. NA Prepress Separator SGK Schawk Redmond Component Type Label Master PID No. NA Prepress Job No. 401616509 EM Part No. NA Comp. PID No. NA Artwork Program Adobe Illustrator CC 2017 Dieline No. LB-PS-1470 v2 Pharma Code NA

ARTWORK SPECIFICS Fonts HelveticaDF-Bold, CondMedium, CondBold, CondBoldItalic; Dialog Cond BoldItalic; Arial-Regular; ITC Zapf Dingbats; OCRB; Helvetica-Bold PANTONE PANTONE Yellow Black 1655 C 2765 C

Active ingredient (in each caplet) Purposes NDC 50580-486-05 than 10 days I fever gets worse or lasts more than 3 days I redness or Ibuprofen 200 mg (NSAID)*...... Pain reliever/fever reducer ® swelling is present in the painful area I any new symptoms appear. If *nonsteroidal anti-inflammatory drug pregnant or breast-feeding, ask a health professional before use. It is 00000000 Uses especially important not to use ibuprofen during the last 3 months of I temporarily relieves minor aches and pains due to: pregnancy unless definitely directed to do so by a doctor because it may I headache I muscular aches I minor pain of arthritis I toothache cause problems in the unborn child or complications during delivery. Keep I backache I the common cold I menstrual cramps Ibuprofen Tablets USP, 200 mg out of reach of children. In case of overdose, get medical help or contact I temporarily reduces fever Pain Reliever/Fever Reducer (NSAID) a Poison Control Center right away. (1-800-222-1222) Warnings Directions I do not take more than directed I the smallest Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in 100 Coated Caplets* *Capsule-Shaped Tablets effective dose should be used. Adults and children 12 years and LOT: EXP. people allergic to aspirin. Symptoms may include: I hives I facial swelling older: I take 1 caplet every 4 to 6 hours while symptoms persist I if pain I asthma (wheezing) I shock I skin reddening I rash I blisters. If an have problems or serious side effects from taking pain relievers or fever or fever does not respond to 1 caplet, 2 caplets may be used I do not allergic reaction occurs, stop use and seek medical help right away. reducers I the stomach bleeding warning applies to you I you have a exceed 6 caplets in 24 hours, unless directed by a doctor. Children under Stomach bleeding warning: This product contains an NSAID, which may history of stomach problems, such as heartburn I you have high blood 12 years: I ask a doctor cause severe stomach bleeding. The chance is higher if you: I are age 60 pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a Other information I store between 20-25°C (68-77°F) I do not use if foil or older I have had stomach ulcers or bleeding problems I take a blood stroke I you are taking a diuretic. Ask a doctor or pharmacist before inner seal imprinted “Sealed For Your Safety” is broken or missing thinning (anticoagulant) or steroid drug I take other drugs containing use if you are I taking aspirin for heart attack or stroke, because Inactive ingredients carnauba wax, colloidal silicon dioxide, FD&C yellow prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or ibuprofen may decrease this benefit of aspirin I under a doctor’s care for no. 6 aluminum lake, hypromellose, iron oxide, magnesium stearate, modified others] I have 3 or more alcoholic drinks every day while using this product any serious condition I taking any other drug. When using this product starch, polydextrose, polyethylene glycol, pregelatinized starch, propylene I take more or for a longer time than directed. Heart attack and stroke I take with food or milk if stomach upset occurs. Stop use and ask a glycol, shellac, sodium starch glycolate, stearic acid, titanium dioxide warning: NSAIDs, except aspirin, increase the risk of heart attack, heart doctor if I you experience any of the following signs of stomach bleeding: Questions or comments? Call 1-877-895-3665 (toll-free) or failure, and stroke. These can be fatal. The risk is higher if you use more I feel faint I vomit blood I have bloody or black stools I have stomach 215-273-8755 (collect) than directed or for longer than directed. Do not use I if you have ever pain that does not get better. I you have symptoms of heart problems or Distributed by: JOHNSON & JOHNSON CONSUMER INC. had an allergic reaction to ibuprofen or any other pain reliever/fever reducer stroke: I chest pain I trouble breathing I weakness in one part or side of McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA I right before or after heart surgery. Ask a doctor before use if I you body I slurred speech I leg swelling. I pain gets worse or lasts more ©J&JCI 20XX www.motrin.com

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18211 NE 68th Street, E120 Redmond, WA 98052 T: 425-881-5454

File Name 401618145_FDASubmissionArt_Motrin_IB_100ct_Label_R2 Product Name MOTRIN IB Coated Caplets

Date 04OCT2019 McNeil Part No. NA Prepress Separator SGK Schawk Redmond Component Type Label Master PID No. NA Prepress Job No. 401618145 EM Part No. NA Comp. PID No. NA Artwork Program Adobe Illustrator CC 2017 Dieline No. LB-PS-1495 v1 Pharma Code NA

ARTWORK SPECIFICS Fonts HelveticaDF-Bold, CondMedium, CondBold, CondBoldItalic; Dialog Cond Italic, BoldItalic; ITC Zapf Dingbats; Arial-Regular PANTONE PANTONE Yellow Black 1655 C 2765 C

Active ingredient (in each caplet) Purposes THIS PACKAGE FOR HOUSEHOLDS Z asthma, or had a stroke I you are taking a diuretic. Ask a doctor or pharmacist before use if you are 00000000 Ibuprofen 200 mg (NSAID)*...... Pain reliever/fever reducer WITHOUT YOUNG CHILDREN LUE SIIZE!! I taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin I under a *nonsteroidal anti-inflammatory drug VAL doctor’s care for any serious condition I taking any other drug. When using this product I take with Uses NDC 50580-486-06 food or milk if stomach upset occurs. Stop use and ask a doctor if I you experience any of the following I temporarily relieves minor aches and pains due to: signs of stomach bleeding: I feel faint I vomit blood I have bloody or black stools I have stomach pain I headache I muscular aches I minor pain of arthritis that does not get better. I you have symptoms of heart problems or stroke: I chest pain I trouble I toothache I backache I the common cold I menstrual cramps breathing I weakness in one part or side of body I slurred speech I leg swelling. I pain gets worse or I temporarily reduces fever ® lasts more than 10 days I fever gets worse or lasts more than 3 days I redness or swelling is present in

EXP: LOT: Warnings the painful area I any new symptoms appear. If pregnant or breast-feeding, ask a health professional Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless to aspirin. Symptoms may include: I hives I facial swelling I asthma (wheezing) I shock definitely directed to do so by a doctor because it may cause problems in the unborn child or complications I skin reddening I rash I blisters. If an allergic reaction occurs, stop use and seek medical during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison help right away. Stomach bleeding warning: This product contains an NSAID, which may Control Center right away. (1-800-222-1222). Directions I do not take more than directed I the cause severe stomach bleeding. The chance is higher if you: I are age 60 or older I have Ibuprofen Tablets USP, 200 mg smallest effective dose should be used. Adults and children 12 years and older: I take 1 caplet had stomach ulcers or bleeding problems I take a blood thinning (anticoagulant) or steroid every 4 to 6 hours while symptoms persist I if pain or fever does not respond to 1 caplet, 2 caplets may be drug I take other drugs containing prescription or nonprescription NSAIDs [aspirin, Pain Reliever/Fever Reducer (NSAID) used I do not exceed 6 caplets in 24 hours, unless directed by a doctor. Children under 12 years: I ask ibuprofen, naproxen, or others] I have 3 or more alcoholic drinks every day while using this a doctor. Other information I store between 20-25°C (68-77°F) I do not use if foil inner seal product I take more or for a longer time than directed. Heart attack and stroke warning: imprinted “Sealed For Your Safety” is broken or missing. Inactive ingredients carnauba wax, NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can colloidal silicon dioxide, FD&C yellow no. 6 aluminum lake, hypromellose, iron oxide, magnesium stearate, be fatal. The risk is higher if you use more than directed or for longer than directed. Do not modified starch, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, sodium use I if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever starch glycolate, stearic acid, titanium dioxide reducer I right before or after heart surgery. Ask a doctor before use if I you have actual size Questions or comments? Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) problems or serious side effects from taking pain relievers or fever reducers I the stomach Distributed by: JOHNSON & JOHNSON CONSUMER INC. bleeding warning applies to you I you have a history of stomach problems, such as McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA heartburn I you have high blood pressure, heart disease, liver cirrhosis, kidney disease, 225 Coated Caplets* *Capsule-Shaped Tablets ©J&JCI 20XX www.motrin.com

HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic NA 4.50 3.50 83% 4.50 5.00 NA 4.50 NA NA -10

18211 NE 68th Street, E120 Redmond, WA 98052 T: 425-881-5454

File Name 401616173_FDASubmissionArt_Motrin_IB_300ct_Label_R3 Product Name MOTRIN IB Coated Caplets

Date 03OCT2019 McNeil Part No. NA Prepress Separator SGK Schawk Redmond Component Type Label Master PID No. NA Prepress Job No. 401616173 EM Part No. NA Comp. PID No. NA Artwork Program Adobe Illustrator CC 2017 Dieline No. LB-PS-1472 v1 Pharma Code NA

ARTWORK SPECIFICS Fonts HelveticaDF-Medium, Cond Medium, Bold, BoldItalic Dialog Cond-Italic, BoldItalic Arial-Regular PANTONE PANTONE Cyan Magenta Yellow Black ITC Zapf Dingbats 1655 C 2765 C Berthold Akzidenz Grotesk-Regular, Bold Trade Gothic Bold Condensed No. 20 Disclaimer Materials & Coatings Helvetica Black • This proof indicates approximate color only! • Artwork must be produced from electronic file. Note: Refer to applicable Specification for • Printer to use pre-approved color targets. • No changes or modifications allowed to exact details/requirements on substrates Graphic Production Manager • All structure and holding lines do not print approved artwork file without written consent and coatings/varnishes. Name Mark Collier unless otherwise indicated. from Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. Phone 1 215 273 4808 Email [email protected] • Printer is responsible for final upc and data matrix code scan quality. Reference ID: 4727725 401618982_FDASubmissionArt_Motrin_IB_300ct_Label_R2.pdf 1 10/4/19 11:27 AM

Active ingredient (in each caplet) Purposes NDC 50580-486-07 benefit of aspirin I under a doctor’s care for any serious condition I taking any other drug. When 00000000 Ibuprofen 200 mg (NSAID)*...... Pain reliever/fever reducer using this product I take with food or milk if stomach upset occurs. Stop use and ask a doctor if *nonsteroidal anti-inflammatory drug ® I you experience any of the following signs of stomach bleeding: I feel faint I vomit blood I have Uses bloody or black stools I have stomach pain that does not get better. I you have symptoms of heart I temporarily relieves minor aches and pains due to: problems or stroke: I chest pain I trouble breathing I weakness in one part or side of body I headache I muscular aches I minor pain of arthritis I slurred speech I leg swelling. I pain gets worse or lasts more than 10 days I fever gets worse or I toothache I backache I the common cold I menstrual cramps lasts more than 3 days I redness or swelling is present in the painful area I any new symptoms I temporarily reduces fever Ibuprofen Tablets USP, 200 mg appear. If pregnant or breast-feeding, ask a health professional before use. It is especially EXP: LOT: Warnings important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Pain Reliever/Fever Reducer (NSAID) so by a doctor because it may cause problems in the unborn child or complications during delivery. Symptoms may include: I hives I facial swelling I asthma (wheezing) I shock I skin reddening Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control I rash I blisters. If an allergic reaction occurs, stop use and seek medical help right away. Stomach Center right away. (1-800-222-1222) bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. Directions I do not take more than directed I the smallest effective dose should be The chance is higher if you: I are age 60 or older I have had stomach ulcers or bleeding problems used. Adults and children 12 years and older: I take 1 caplet every 4 to 6 hours while I take a blood thinning (anticoagulant) or steroid drug I take other drugs containing prescription or symptoms persist I if pain or fever does not respond to 1 caplet, 2 caplets may be used I do not nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] I have 3 or more alcoholic drinks every exceed 6 caplets in 24 hours, unless directed by a doctor. Children under 12 years: I ask a doctor day while using this product I take more or for a longer time than directed. Heart attack and stroke Other information I store between 20-25°C (68-77°F) I do not use if foil inner seal imprinted warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can “Sealed For Your Safety” is broken or missing be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use I if you Inactive ingredients carnauba wax, colloidal silicon dioxide, FD&C yellow no. 6 aluminum lake, have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer I right before or hypromellose, iron oxide, magnesium stearate, modified starch, polydextrose, polyethylene glycol, after heart surgery. Ask a doctor before use if I you have problems or serious side effects from taking pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, stearic acid, titanium dioxide pain relievers or fever reducers I the stomach bleeding warning applies to you I you have a history of Questions or comments? Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) stomach problems, such as heartburn I you have high blood pressure, heart disease, liver cirrhosis, 300 Distributed by: JOHNSON & JOHNSON CONSUMER INC. kidney disease, asthma, or had a stroke I you are taking a diuretic. Ask a doctor or pharmacist McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA before use if you are I taking aspirin for heart attack or stroke, because ibuprofen may decrease this Coated Caplets* *Capsule-Shaped Tablets ©J&JCI 20XX www.motrin.com

HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic NA 4.50 3.50 90% 4.50 5.00 NA 4.50 NA NA -10

18211 NE 68th Street, E120 Redmond, WA 98052 T: 425-881-5454

File Name 401618982_FDASubmissionArt_Motrin_IB_300ct_Label_R2 Product Name MOTRIN IB Coated Caplets

Date 04OCT2019 McNeil Part No. NA Prepress Separator SGK Schawk Redmond Component Type Label Master PID No. NA Prepress Job No. 401618982 EM Part No. NA Comp. PID No. NA Artwork Program Adobe Illustrator CC 2017 Dieline No. LB-PS-1472 v1 Pharma Code NA

ARTWORK SPECIFICS Fonts HelveticaDF-Medium, Bold, CondMedium, CondBold, CondBoldItalic; Dialog Cond-Italic, BoldItalic; Arial-Regular; ITC Zapf Dingbats; Berthold Akzidenz PANTONE PANTONE Yellow Black Grotesk-Regular, Bold 1655 C 2765 C

Active ingredient (in each caplet) Purposes For Hospital and Government Use Only I take with food or milk if stomach upset occurs. Stop use and ask a doctor if I you Ibuprofen 200 mg (NSAID)*...... Pain reliever/fever reducer experience any of the following signs of stomach bleeding: I feel faint I vomit blood I have *nonsteroidal anti-inflammatory drug bloody or black stools I have stomach pain that does not get better. I you have symptoms of Uses heart problems or stroke: I chest pain I trouble breathing I weakness in one part or side of I temporarily relieves minor aches and pains due to: body I slurred speech I leg swelling. I pain gets worse or lasts more than 10 days I fever I headache I muscular aches I minor pain of arthritis gets worse or lasts more than 3 days I redness or swelling is present in the painful area I toothache I backache I the common cold I menstrual cramps I any new symptoms appear. If pregnant or breast-feeding, ask a health professional I temporarily reduces fever before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy 00000000 Warnings NDC 50580-486-02 unless definitely directed to do so by a doctor because it may cause problems in the unborn Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic child or complications during delivery. Keep out of reach of children. In case of overdose, to aspirin. Symptoms may include: I hives I facial swelling I asthma (wheezing) get medical help or contact a Poison Control Center right away. (1-800-222-1222) I shock I skin reddening I rash I blisters. If an allergic reaction occurs, stop use and Directions seek medical help right away. Stomach bleeding warning: This product contains an I do not take more than directed I the smallest effective dose should be used NSAID, which may cause severe stomach bleeding. The chance is higher if you: Adults and children 12 years and older: I take 1 caplet every 4 to 6 hours while I are age 60 or older I have had stomach ulcers or bleeding problems I take a blood symptoms persist I if pain or fever does not respond to 1 caplet, 2 caplets may be used EXP: LOT: thinning (anticoagulant) or steroid drug I take other drugs containing prescription or I do not exceed 6 caplets in 24 hours, unless directed by a doctor. Children under 12 years: nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] I have 3 or more I ask a doctor alcoholic drinks every day while using this product I take more or for a longer time than Ibuprofen Tablets USP, 200 mg Other information directed. Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of I store between 20-25°C (68-77°F) I do not use if foil inner seal imprinted “Sealed heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more For Your Safety” is broken or missing than directed or for longer than directed. Do not use I if you have ever had an allergic Pain Reliever / Fever Reducer (NSAID) Inactive ingredients reaction to ibuprofen or any other pain reliever/fever reducer I right before or after heart carnauba wax, colloidal silicon dioxide, FD&C yellow no. 6 aluminum lake, hypromellose, iron surgery. Ask a doctor before use if I you have problems or serious side effects from oxide, magnesium stearate, modified starch, polydextrose, polyethylene glycol, pregelatinized taking pain relievers or fever reducers I the stomach bleeding warning applies to you starch, propylene glycol, shellac, sodium starch glycolate, stearic acid, titanium dioxide I you have a history of stomach problems, such as heartburn I you have high blood Questions or comments? Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke I you are taking a diuretic. Ask a doctor or pharmacist before use if you are I taking aspirin for 500 Distributed by: JOHNSON & JOHNSON CONSUMER INC. heart attack or stroke, because ibuprofen may decrease this benefit of aspirin I under a McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA doctor’s care for any serious condition I taking any other drug. When using this product Coated Caplets* *Capsule-Shaped Tablets ©J&JCI 20XX www.motrin.com

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18211 NE 68th Street, E120 Redmond, WA 98052 T: 425-881-5454

File Name 401616565_FDASubmissionArt_Motrin_IB_HG_500ct_Label_R2 Product Name MOTRIN IB Coated Caplets

Date 03OCT2019 McNeil Part No. NA Prepress Separator SGK Schawk Redmond Component Type Label Master PID No. NA Prepress Job No. 401616565 EM Part No. NA Comp. PID No. NA Artwork Program Adobe Illustrator CC 2017 Dieline No. LB-PS-1473 v1 Pharma Code NA

ARTWORK SPECIFICS Fonts HelveticaDF-Bold, CondMedium, CondBold, CondBoldItalic; Dialog Cond-Italic, BoldItalic; Arial-Regular; ITC Zapf Dingbats; Berthold Akzidenz PANTONE PANTONE Yellow Black Grotesk-Regular, Bold; Helvetica LT Std - Roman 1655 C 2765 C

Disclaimer Materials & Coatings • This proof indicates approximate color only! • Artwork must be produced from electronic file. Note: Refer to applicable Specification for • Printer to use pre-approved color targets. • No changes or modifications allowed to exact details/requirements on substrates Graphic Production Manager • All structure and holding lines do not print approved artwork file without written consent and coatings/varnishes. Name Mark Collier unless otherwise indicated. from Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division. Phone 1 215 273 4808 Email [email protected] • Printer is responsible for final upc and data matrix code scan quality. Reference ID: 4727725 401619061_FDASubmissionArt_Motrin_IB_2ct_Pouch_R2.pdf 1 10/4/19 9:54 AM 2 allergic reaction, especially in people allergic to aspirin. Symptoms may include: include: may Symptoms aspirin. to allergic people in especially reaction, allergic and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. directed. than longer for or directed than more use you if higher is risk The fatal. be can These stroke. and Heart and attack stroke warning: containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] others] or naproxen, ibuprofen, [aspirin, NSAIDs nonprescription or prescription containing cause severe stomach bleeding. The chance is higher if you: you: if higher is chance The bleeding. stomach severe cause may which NSAID, an contains Stomach product bleeding warning: away. This right help medical seek I I to: to: more alcoholic drinks every day while using this product product this using while day every drinks alcoholic more ulcers or bleeding problems problems bleeding or ulcers use not Do Pain I asthma (wheezing) (wheezing) asthma cramps menstrual Ibuprofen Tablets effects from taking pain relievers or fever reducers reducers fever or relievers pain taking from effects Ask a doctor before use if if use before a doctor Ask surgery. heart after or before right Coated Caplet I I headache you have a history of stomach problems, such as heartburn heartburn as such problems, stomach of a history have you Reliever heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke a stroke had or asthma, disease, kidney cirrhosis, liver disease, heart I if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer reducer reliever/fever pain other any or ibuprofen to reaction allergic an had ever have you if under a I store between take with food (collect) I I / 00000000 I muscular aches aches muscular

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18211 NE 68th Street, E120 Redmond, WA 98052 T: 425-881-5454

File Name 401619061_FDASubmissionArt_Motrin_IB_2ct_Pouch_R2 Product Name MOTRIN IB Coated Caplets

Date 04OCT2019 McNeil Part No. NA Prepress Separator SGK Schawk Redmond Component Type Pouch Master PID No. NA Prepress Job No. 401619061 EM Part No. NA Comp. PID No. NA Artwork Program Adobe Illustrator CC 2017 Dieline No. UNWIND-211 v2 Pharma Code NA

ARTWORK SPECIFICS Fonts HelveticaDF-Cond Bold, Cond Black, Cond Black Italic; Dialog-Cond Italic, Cond Bold Italic; ITC Zapf Dingbats; OCRB PANTONE PANTONE Yellow Black 1655 C 2765 C

Reference ID: 4727725

401614720_FDASubmissionArt_Motrin_IB_24ct_Carton_R2.pdf 1 10/3/19 1:18 PM

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Drug Facts (continued) Other informationMM I store between 20-25°C (68-77°F) I do not use if carton is opened. Do not use if foil inner seal imprinted with “Sealed For Your Safety” is broken or missing Inactive ingredients carnauba wax, colloidal silicon dioxide, FD&C yellow no. 6 aluminum lake, hypromellose, iron oxide, magnesium stearate, modified starch, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, stearic acid, titanium dioxide Questions or comments? Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Distributed by: JOHNSON & JOHNSON CONSUMER INC. McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA ©J&JCI 20XX www.motrin.com

HelveticaDF-Cond Medium, Cond Bold, Cond Bold Italic 8.50 6.00 5.00 65% 8.00 6.50 2.50 6.00 8.00 0.50 0

18211 NE 68th Street, E120 Redmond, WA 98052 2 (width x height) 4.83 in T: 425-881-5454 (2.81 x 1.72) File Name 401614720_FDASubmissionArt_Motrin_IB_24ct_Carton_R2 0.0625 in Product Name MOTRIN IB Coated Caplets

Date 03OCT2019 McNeil Part No. NA Prepress Separator SGK Schawk Redmond Component Type Carton Master PID No. NA Prepress Job No. 401614720 EM Part No. NA Comp. PID No. NA Artwork Program Adobe Illustrator CC 2017 Dieline No. FC-C-1524 v1 Pharma Code NA

ARTWORK SPECIFICS Fonts HelveticaDF-Bold, CondMedium, CondBold, CondBoldItalic; Dialog Cond BoldItalic; Arial-Regular; ITC Zapf Dingbats; Helvetica Neue LT Std - 67 Medium PANTONE PANTONE Yellow Black Condensed; OCRB 1655 C 2765 C

Reference ID: 4727725

401618102_FDASubmissionArt_Motrin_IB_50ct_Carton_R2.pdf 1 10/4/19 11:46 AM

-02 481 5-0 004 3 3

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18211 NE 68th Street, E120 Redmond, WA 98052 2 T: 425-881-5454 (width x height) 4.83 in (2.81 x 1.72) File Name 401618102_FDASubmissionArt_Motrin_IB_50ct_Carton_R2 Product Name MOTRIN IB Coated Caplets 0.0625 in

Date 04OCT2019 McNeil Part No. NA Prepress Separator SGK Schawk Redmond Component Type Carton Master PID No. NA Prepress Job No. 401618102 EM Part No. NA Comp. PID No. NA Artwork Program Adobe Illustrator CC 2017 Dieline No. FC-C-1524 v1 Pharma Code NA

ARTWORK SPECIFICS Fonts HelveticaDF-Bold, CondMedium, CondBold, CondBoldItalic; Dialog Cond BoldItalic; Arial-Regular; ITC Zapf Dingbats; OCRB PANTONE PANTONE Yellow Black 1655 C 2765 C

Reference ID: 4727725

401616515_FDASubmissionArt_Motrin_IB_HG_60ct_Carton_R2.pdf 1 10/3/19 1:26 PM

00000000

EXP: LOT:

Drug Facts (continued) Drug Facts (continued) Important: Read all product information before using. nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] Keep this box for important information. I you have symptoms of heart problems or stroke: actual size I have 3 or more alcoholic drinks every day while using this product I chest pain MM I trouble breathing I take more or for a longer time than directed I weakness in one part or side of body Drug Facts Heart attack and stroke warning: NSAIDs, except aspirin, increase I I slurred speech MM leg swelling *Capsule-Shaped Tablets Active ingredient (in each caplet) Purposes the risk of heart attack, heart failure, and stroke. These can be fatal. I pain gets worse or lasts more than 10 days NDC 50580-486-01 Ibuprofen 200 mg (NSAID)*...... Pain reliever/fever reducer The risk is higher if you use more than directed or for longer than directed. I fever gets worse or lasts more than 3 days ® *nonsteroidal anti-inflammatory drug Do not use I redness or swelling is present in the painful area g Uses I I m

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