how can we help? 1-877-895-3665 · 1-877-895-3665, as ... (34 to 47 bs) do not use children under 2...

13
TEAR OFF A SECTION 1 FOLD CORNER INWARD AND PEEL BACK FOIL 2 Distributed by: JOHNSON & JOHNSON CONSUMER INC. McNeil Consumer Healthcare Division Fort Washington, PA 19034 USA ©J&JCI 2016 www.imodium.com U.S. Patent No. 6,103,260 ® How can we help? 1-877-895-3665 Loperamide HCl, 2 mg /Simethicone, 125 mg Antidiarrheal/Anti-gas ® Caplet Multi-Symptom Relief • Cramps & Pressure • Bloating • Gas Relieves symptoms of diarrhea plus See New Warning and Directions Actual Size *capsule-shaped tablets 12 Caplets* Inactive ingredients acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid Drug Facts (continued) Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect) Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl Heart alert: Taking more than directed can cause serious heart problems or death Do not use if you have bloody or black stool f you have difficulty swallowing Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas Active ingredients (in each caplet) Purposes Loperamide HCl 2 mg…………………….. ……....... ...... ........... Anti-diarrheal Simethicone 125 mg………………………………....... ............. .............. Anti-gas Drug Facts Ask a doctor before use if you have fever mucus in the stool a history of liver disease If pregnant or breast-feeding, ask a hea th professional before use. Keep out of reach of children. Drug Facts (continued) Stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swel ing or bulging. These may be signs of a serious cond tion. you have difficulty swallowing the caplet Ask a doctor or pharmacist before use if you are taking antibiotics Other information each caplet contains: calcium 165 mg, sodium 3 mg store between 20-25°C (68 -77°F). Protect from light. do not use if carton is open or if blister unit is open or torn Directions drink plenty of clear fluids to help prevent dehydration caused by diarrhea take only on an empty stomach (1 hour before or 2 hours after a meal) take w th a full (8 oz.) glass of water find right dose on chart below. f possible, use weight to dose; otherwise, use age. When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours 1 caplet after the first loose stool; 1 / 2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours 1 caplet after the first loose stool; / 2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours ask a doctor adults and children 12 years and over children 9-11 years (60-95 lbs) ch ldren 6-8 years (48-59 lbs) children 2-5 years (34 to 47 bs) do not use children under 2 years (up to 33 bs) In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 00000000 LOT EXP NDC 50580-338-12 00000000 00000000 00000000 Reference ID: 4083274

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TEAR OFF A SECTIO

N1

FOLD CO

RNER INW

ARDAN

D PEEL BACK FOIL

2

Dist

ribut

ed b

y:JO

HN

SON

& JO

HN

SON

CON

SUM

ER IN

C.

McN

eil C

onsu

mer

Hea

lthca

re D

ivisio

nFo

rt W

ashi

ngto

n, P

A 19

034

USA

©J&

JCI 2

016

w

ww

.imod

ium

.com

U.S.

Pat

ent N

o. 6

,103,

260

®

How can we help? 1-877-895-3665

Loperamide HCl, 2 mg /Simethicone, 125 mg Antidiarrheal/Anti-gas

®

CapletMulti-Symptom Relief

• Cramps & Pressure• Bloating • Gas

Relieves symptomsof diarrhea plus

See New Warning and Directions

Actual Size*capsule-shaped tablets

12 Caplets*

Inactive ingredientsacesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid

Drug Facts (continued)

Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

WarningsAllergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HClHeart alert: Taking more than directed can cause serious heart problems or deathDo not use■ if you have bloody or black stool ■ f you have difficulty swallowing

Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Active ingredients (in each caplet) PurposesLoperamide HCl 2 mg……………………..…….............…...........Anti-diarrhealSimethicone 125 mg………………………………..................................Anti-gas

Drug Facts

Ask a doctor before use if you have ■ fever ■ mucus in the stool ■ a history of liver disease

If pregnant or breast-feeding, ask a heath professional before use. Keep out of reach of children.

Drug Facts (continued)

Stop use and ask a doctor if ■ symptoms get worse ■ diarrhea lasts for more than 2 days ■ you get abdominal sweling or bulging. These may be signs of a serious condtion.■ you have difficulty swallowing the caplet

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

Other information ■ each caplet contains: calcium 165 mg, sodium 3 mg■ store between 20-25°C (68 -77°F). Protect from light.

■ do not use if carton is open or if blister unit is open or torn

Directions ■ drink plenty of clear fluids to help prevent dehydration

caused by diarrhea■ take only on an empty stomach (1 hour before or 2 hours after a meal)■ take wth a full (8 oz.) glass of water■ find right dose on chart below. f possible, use weight to dose; otherwise, use age.

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours1 caplet after the first loose stool; /2 caplet after each subsequent loose stool;

but no more than 2 caplets in 24 hoursask a doctor

adults and children 12 years and over

children 9-11 years(60-95 lbs)

chldren 6-8 years (48-59 lbs)

children 2-5 years (34 to 47 bs)

do not use children under 2 years (up to 33 bs)

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

00000000

LOT

EX

P

NDC 50580-338-12

00000000

00000000

00000000

Reference ID: 4083274

TEAR OFF A SEC

TION1

FOLD

AND

TEAR AT NO

TCH

2

Dist

ribut

ed b

y:JO

HN

SON

& JO

HN

SON

CON

SUM

ER IN

C.

McN

eil C

onsu

mer

Hea

lthca

re D

ivisio

nFo

rt W

ashi

ngto

n, P

A 19

034

USA

©J&

JCI 2

016

ww

w.im

odiu

m.c

omU.

S. P

aten

t No.

6,10

3,26

0

®

How can we help? 1-877-895-3665

Loperamide HCl, 2 mg /Simethicone, 125 mg Antidiarrheal/Anti-gas

®

CapletMulti-Symptom Relief

• Cramps & Pressure• Bloating • Gas

Relieves symptomsof diarrhea plus

See New Warning and Directions

*capsule-shaped tablets

12 Caplets*Actual Size

Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

WarningsAllergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HClHeart alert: Taking more than directed can cause serious heart problems or death

Do not use■ if you have bloody or black stool ■ if you have difficulty swallowing

Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Active ingredients (in each caplet) PurposesLoperamide HCl 2 mg…………………….……..............…...Anti-diarrhealSimethicone 125 mg………………………………............................Anti-gas

Drug Facts

Ask a doctor before use if you have ■ fever ■ mucus in the stool ■ a history of liver disease

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

Drug Facts (continued)

Stop use and ask a doctor if ■ symptoms get worse ■ diarrhea lasts for more than 2 days■ you get abdominal swelling or bulging. These may be signs of a serious condition.■ you have dificulty swalowing the caplet

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

Other information ■ each caplet contains: calcium 165 mg, sodium 3 mg ■ store between 20-25°C (68 -77°F). Protect from light. ■ do not use if carton is open or if blister unit is open or torn

Directions ■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea■ take only on an empty stomach (1 hour before or 2 hours after a meal)■ take with a full (8 oz.) glass of water■ ind right dose on chart below. If possible, use weight to dose; otherwise, use age.

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Inactive ingredientsacesulfame potassium, croscarmelose sodium, dibasic calcium phosphate, lavor, microcrystalline cellulose, stearic acid

Drug Facts (continued)

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hoursask a doctor

aduts and children 12 years and over

chldren 9-11 years(60-95 lbs)

children 6-8 years (48-59 lbs)

chldren 2-5 years (34 to 47 lbs)

do not use chldren under 2 years (up to 33 lbs)

00

00

00

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LOT

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NDC 50580-338-12

00000000

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Reference ID: 4083274

Dis

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®

How can we help? 1-877-895-3665

Loperamide HCl, 2 mg /Simethicone, 125 mg Antidiarrheal/Anti-gas

®

CapletMulti-Symptom Relief

• Cramps & Pressure• Bloating • Gas

Relieves symptomsof diarrhea plus

See New Warning and Directions

Actual Size*capsule-shaped tablets

18 Caplets*

Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

WarningsAllergy alert Do not use if you have ever had a rash or other allergic reaction to loperamide HClHeart alert Taking more than directed can cause serious heart problems or death

Do not use■ if you have bloody or black stool ■ if you have difficulty swallowing

Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Active ingredients (in each caplet) PurposesLoperamide HCl 2 mg……………………..…….............…...Anti-diarrhealSimethicone 125 mg………………………………............................Anti-gas

Drug Facts

Ask a doctor before use if you have ■ fever ■ mucus in the stool ■ a history of liver disease

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

Drug Facts (continued)

Stop use and ask a doctor if ■ symptoms get worse ■ diarrhea lasts for more than 2 days■ you get abdominal swelling or bulging. These may be signs of a serious condition.■ you have dificulty swallowing the caplet

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

Other information ■ each caplet contains: calcium 165 mg, sodium 3 mg ■ store between 20-25°C (68 -77°F). Protect from ight. ■ do not use if carton is open or if blister unit is open or torn

Directions ■ drink plenty of clear fluids to help prevent dehydration

caused by diarrhea■ take only on an empty stomach (1 hour before or 2 hours ater a meal)■ take with a full (8 oz.) glass of water■ find right dose on chart below. If possble, use weight to dose; otherwise, use age.

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Inactive ingredientsacesulfame potassium, croscarmelose sodium, dibasic calcium phosphate, lavor, microcrystalline cellulose, stearic acid

Drug Facts (continued)

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours1 caplet after the first loose stool; /2 caplet after each subsequent loose stool;

but no more than 2 caplets in 24 hoursask a doctor

adults and children 12 years and over

children 9-11 years(60-95 lbs)

children 6-8 years (48-59 lbs)

children 2-5 years (34 to 47 bs)

do not use children under 2 years (up to 33 bs)

LOT

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NDC 50580-338-18

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TEAR OFF A SECTIO

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2

Reference ID: 4083274

Dis

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ted

by:

JOH

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OH

NS

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ON

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6,1

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60

TEAR OFF A SEC

TION1

FOLD

AND

TEAR AT NO

TCH

2

®

How can we help? 1-877-895-3665

Loperamide HCl, 2 mg /Simethicone, 125 mg Antidiarrheal/Anti-gas

®

CapletMulti-Symptom Relief

• Cramps & Pressure• Bloating • Gas

Relieves symptomsof diarrhea plus

See New Warning and Directions

Actual Size*capsule-shaped tablets

18 Caplets*

Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

WarningsAllergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HClHeart alert: Taking more than directed can cause serious heart problems or death

Do not use■ if you have bloody or black stool ■ if you have difficulty swallowing

Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Active ingredients (in each caplet) PurposesLoperamide HCl 2 mg……………………..…….............…...Anti-diarrhealSimethicone 125 mg………………………………............................Anti-gas

Drug Facts

Ask a doctor before use if you have ■ fever ■ mucus in the stool ■ a history of liver disease

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.

Drug Facts (continued)

Stop use and ask a doctor if ■ symptoms get worse ■ diarrhea lasts for more than 2 days■ you get abdominal swelling or bulging. These may be signs of a serious condition.■ you have dificulty swallowing the caplet

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

Other information ■ each caplet contains: calcium 165 mg, sodium 3 mg ■ store between 20-25°C (68 -77°F). Protect from ight. ■ do not use if carton is open or if blister unit is open or torn

Directions ■ drink plenty of clear fluids to help prevent dehydration

caused by diarrhea■ take only on an empty stomach (1 hour before or 2 hours ater a meal)■ take wth a ful (8 oz.) glass of water■ ind right dose on chart below. If possible, use weight to dose; otherwise, use age.

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Inactive ingredientsacesulfame potassium, croscarmelose sodium, dibasic calcium phosphate, lavor, microcrystalline cellulose, stearic acid

Drug Facts (continued)

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours1 caplet after the first loose stool; /2 caplet after each subsequent loose stool;

but no more than 3 caplets in 24 hours1 caplet after the first loose stool; /2 caplet after each subsequent loose stool;

but no more than 2 caplets in 24 hoursask a doctor

adults and children 12 years and over

children 9-11 years(60-95 lbs)

children 6-8 years (48-59 bs)

children 2-5 years (34 to 47 lbs)

do not use children under 2 years (up to 33 lbs)

LOT

:

EX

P:

00000000

NDC 50580-338-18

00000000 0000

0000

00000000

30045-0212-184

Reference ID: 4083274

®

How

can we help?

1-877-8

95-3

66

5Multi-Symptom Relief30 Caplets

Loperamide HCI, 2 mg/Simethicone, 125 mg Antidiarrheal/Anti-gas

®

Multi-Symptom ReliefCaplet

NDC 50580-338-30

Loperamide HCI, 2 mg/Simethicone, 125 mg Antidiarrheal/Anti-gas

®

See New Warning and Directions

• Cramps & Pressure• Bloating • Gas

Relieves symptomsof diarrhea plus

Actual Size

30 Caplets*

*capsule-shaped tablets

Do not use ■ f you have bloody or black stool ■ if you have difficulty swallowingAsk a doctor before use if you have ■ fever ■ mucus in the stool ■ a history of liver disease

Stop use and ask a doctor if ■ symptoms get worse■ diarrhea lasts for more than 2 days ■ you get abdominal swelling or bulging. These may be signs of a serious condition.■ you have difficulty swallowing the caplet

Ask a doctor or pharmacist before use if you are taking antibioticsWhen using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours

adults and children 12 yearsand overchildren9-11 years(60-95 lbs)

children6-8 years (48-59 lbs)

WarningsAllergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HClHeart alert: Taking more than directed can cause serious heart problems or death

Uses reieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Active ingredients Purposes(in each caplet)Loperamide HCl 2 mg………............Anti-diarrhealSimethicone 125 mg….....….....................Anti-gas

Drug FactsDrug Facts (continued)

Other information ■ each caplet contains: calcium 165 mg, sodium 3 mg ■ store between 20-25°C (68-77°F). Protect from light. ■ do not use if carton is open or if printed foil seal under bottle cap is open or torn

Drug Facts (continued)

Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Drug Facts (continued)

Drug Facts (continued)

Distributed by:JOHNSON & JOHNSON CONSUMER INC.McNeil Consumer Healthcare DivisionFort Washington, PA 19034 USA©J&JCI 2016www.imodium.com U.S. Patent No. 6,103,260

ask a doctor children 2-5 years (34 to 47 lbs)

do not use children under 2 years (up to 33 lbs)

Inactive ingredients acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, lavor, microcrystalline cellulose, stearic acid

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions ■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea■ take only on an empty stomach (1 hour before or 2 hours after a meal)■ take with a full (8 oz.) glass of water■ find right dose on chart. f possible, use weight to dose; otherwise, use age.

Drug Facts (continued)

LOT:

EXP.

0000

0000

00000000

00000000

Reference ID: 4083274

30 Caplets*30 Caplets*

NDC 50580 338 30

Multi-Symptom Relief

Loperamide HCI, 2 mg/Simethicone, 125 mgAntidiarrheal/Anti-gas

®

*capsule shaped tablets

LOT:

EXP:eve had a ash or o her al e gic reac on o ope am de HCl. Heart alert: Taking more han directed can ause serious heart p oblems or dea h. Do not use • if you have bloody or black stool • if ou have di ficulty swallowing. Ask a doctor before use if you have • fever • mu us in he stool • a history of liver disease.

Active ing edients (in ea h aplet) PurposesLope amide HCl 2 mg. .... .... .... .... ... .... Anti diar healSime hicone 25 mg.. .... .... .... .... ... .... .... ....An i gasUses relieves symptoms of diar hea plus bloating, pressure and c amps, ommonly refer ed to as gasWarnings: Allergy alert: Do not use if you have

As a doctor or pharmacist befo e use f you a e taking ant biotics. When using his p oduct tiredness, wsiness or dizziness may oc ur. Be careful when driving or ope ating ma hinery. Stop use and ask a doctor

f • symptoms get worse diar hea lasts for more han 2 days • you get abdominal swelling or bulging. These may be signs of a serious ondition. • you have diffi ulty swallowing he aplet. If p egnant or breast-feeding, ask a heal h p ofessional before use. Keep out of each of chi d en. In case of ove dose get medical help or ontact a Po son Cont ol Center right away. (1 800 222-1222) Directions • drink plenty of clear flu ds to help p event dehydration caused by diar hea • take only on an empty stomach (1 hour before or 2 hou s after a meal) • take wi h a full (8 oz.) glass of water • If poss ble, use weight to dose; o herwise, use age. Adu ts and chi d en 12 yea s and over: 2 aplets after he fi st loose stool; 1 caplet after ea h subsequent loose stool; but no more han 4 aplets in 24 hou s. Chi d en 9-11 years (60-95 lbs): 1 aplet after he fi st loose stool; 1/2 aplet after each subsequent l e stool; but no more han 3 caplets in 24 hours. Chi d en 6-8 years (48-59 lbs): 1 caplet after he fi st loose

l; 1/2 caplet after ea h subsequent loose stool; but no more than 2 aplets in 24 hou s. i d en 2-5 years (34 to 47 lbs) ask a doctor. Chi d en under 2 yea s (up to 33 lbs) do not use

Other information ea h aplet ontains: calcium 165 mg, sodium 3 mg • store between 20 25°C (68-77°F). P otect f om light. • do not use f printed foil seal on bottle is b oken or missing Questions or comments? call 1-877-895-3665 (to l-free) or 215-273-8755 ( ollect)Distr buted by JOHNSON & JOHNSON CONSUMER INC.McNeil Consumer Healthcare Division, Fort Washington, PA 19034 USA ©J&JCI 2016www.imodium.com U S Patent No 6,103,260

00000000

Reference ID: 4083274

Multi-Symptom Relief30 Caplets

Loperamide HCI, 2 mg/Simethicone, 125 mg Antidiarrheal/Anti-gas

How

can we help?

1-877-8

95-3

66

5

Multi-Symptom ReliefCaplet

NDC 50580-338-30

Loperamide HCI, 2 mg/Simethicone, 125 mg Antidiarrheal/Anti-gas

®

®

See New Warning and Directions

• Cramps & Pressure• Bloating • Gas

Relieves symptomsof diarrhea plus

Actual Size

30 Caplets*

*capsule-shaped tablets

®

Other information ■ each caplet contains: calcium 165 mg, sodium 3 mg ■ store between 20-25°C (68-77°F). Protect from ight. ■ do not use if carton is open or if printed foil seal under bottle cap is open or torn

Drug Facts (continued)

Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Drug Facts (continued)

Distributed by:JOHNSON & JOHNSON CONSUMER INC.McNeil Consumer Healthcare DivisionFort Washington, PA 19034 USA©J&JCI 2016www.imodium.com U.S. Patent No. 6,103,260

ask a doctor children 2-5 years (34 to 47 bs)

do not use children under 2 years (up to 33 bs)

Inactive ingredients acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, lavor, microcrystalline cellulose, stearic acid

Do not use ■ if you have bloody or black stool ■ if you have dfficulty swallowingAsk a doctor before use if you have ■ fever ■ mucus in the stool ■ a history of liver disease

Stop use and ask a doctor if ■ symptoms get worse■ diarrhea lasts for more than 2 days ■ you get abdominal swelling or bulging. These may be signs of a serious condition.■ you have dfficulty swallowing the caplet

Ask a doctor or pharmacist before use if you are taking antibioticsWhen using this product tiredness, drowsiness or dizziness may occur Be careful when driving or operating machinery.

2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours

adults and children 12 yearsand overchildren9-11 years(60-95 lbs)

children6-8 years (48-59 bs)

WarningsAllergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HClHeart alert: Taking more than directed can cause serious heart problems or death

Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Active ingredients Purposes(in each caplet)Loperamide HCl 2 mg………............Anti-diarrhealSimethicone 125 mg…....….....................Anti-gas

Drug FactsDrug Facts (continued)

Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions ■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea■ take only on an empty stomach (1 hour before or 2 hours after a meal)■ take with a full (8 oz.) glass of water■ find right dose on chart. f possible, use weight to dose; otherwise, use age.

Drug Facts (continued)

0000

0000

/000

000

000000

000000

Reference ID: 4083274

30 Caplets*30 Caplets*

NDC 50580 338 30

Multi-Symptom Relief

Loperamide HCI, 2 mg/Simethicone, 125 mgAntidiarrheal/Anti-gas

®

*capsule shaped tablets

Direc ions • drink plenty of clear fluids to help prevent dehydration caused by diarrhea • take only on an empty stoma h (1 hour before or 2 hou s after a meal) • take w h a full (8 oz.) glass of water • find right dose on chart. If possible, use weight to dose; o herwise, use age.

1 caplet after he i st loose stool; /2 caplet after each subsequent loose stool; but no more han 3 caplets in 24 hou s

hi d en 9-11 yea s (60 95 bs)

adu ts and hi d en 2 yea s and over

2 caple s after he f rst oose s ool; 1 caplet a ter each subsequent loose stool; but no more han 4 aplets in 24 hou s

1 caplet after he i st loose stool; /2 caplet after each subsequent loose stool; but no more han 2 caplets in 24 hou s

hi d en 6-8 yea s (48 59 bs)

ask a doctorhi d en 2 5 yea s (34 to 47 lbs)

do not usehi d en under 2 yea s (up to 33 lbs)

Active ingredients (in each caplet) PurposesLope amide HCl 2 mg...... ...... ....... ...... ....... ...... ........ Anti diarrhealSime hicone 125 mg...... ....... ...... ....... ...... ....... ...... ....... ... Anti gasUses re ieves symptoms of diar hea plus bloating, pressure and c amps, commonly referred to as gasWarn ngs: Allergy alert: Do not use if you have ever had a ash or o her alle gic reaction to lope amide HCl. Heart alert Taking more han directed an ause serious heart problems or dea h. Do not

use • if you have bloody or black stool • if you have d f icu ty swallowing. Ask a doctor befo e use if you ha e • fever • mu us in he stool • a history of liver disease. Ask a doctor or pharmacist before use if you are taking ant biotics. When using his

p oduct tiredness, drowsiness or dizziness may occur. Be areful when driving or ope ating ma hinery. Stop use and ask a doctor if symptoms get worse • diar hea lasts for more han 2 days • you get abdominal swel ing or bulging. These may be signs of a serious cond tion. • you have d fficulty swallowing he caplet. If pregnant or b east-feeding, ask a heal h professional before use. Keep out of each of chi dren. In case of overdose, get medica help or contact a Poison Control Center right away. (1 800 222- 222)

O her informa ion • each caplet contains: calcium 165 mg, sodium 3 mg • store between 20 25°C (68-77°F). Protect from ight. • do not use if printed foil seal on bottle is broken or missingQues ions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Distributed by: JOHNSON & JOHNSON CONSUMER INC.

McNeil Consumer Healthcare DivisionFort W

ashington, PA 19034 USA ©J&JCI 2016 US6,103,26000000000

000000

EX

P. LO

T:

Reference ID: 4083274

®

How

can we help?

1-877-8

95-3

66

5Multi-Symptom Relief42 Caplets

Loperamide HCI, 2 mg/Simethicone, 125 mg Antidiarrheal/Anti-gas

®

Multi-Symptom ReliefCaplet

NDC 50580-338-42

Loperamide HCI, 2 mg/Simethicone, 125 mg Antidiarrheal/Anti-gas

®

See New Warning and Directions

• Cramps & Pressure• Bloating • Gas

Relieves symptomsof diarrhea plus

Actual Size

42 Caplets*

*capsule-shaped tablets Actual SiSize

Do not use ■ f you have bloody or black stool ■ if you have difficulty swallowingAsk a doctor before use if you have ■ fever ■ mucus in the stool ■ a history of liver disease

Stop use and ask a doctor if ■ symptoms get worse■ diarrhea lasts for more than 2 days ■ you get abdominal swelling or bulging. These may be signs of a serious condition.■ you have difficulty swallowing the caplet

Ask a doctor or pharmacist before use if you are taking antibioticsWhen using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours

adults and children 12 yearsand overchildren9-11 years(60-95 lbs)

children6-8 years (48-59 lbs)

WarningsAllergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HClHeart alert: Taking more than directed can cause serious heart problems or death

Uses reieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Active ingredients Purposes(in each caplet)Loperamide HCl 2 mg………............Anti-diarrhealSimethicone 125 mg….....….....................Anti-gas

Drug FactsDrug Facts (continued)

Other information ■ each caplet contains: calcium 165 mg, sodium 3 mg ■ store between 20-25°C (68-77°F). Protect from light. ■ do not use if carton is open or if printed foil seal under bottle cap is open or torn

Drug Facts (continued)

Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Drug Facts (continued)

Drug Facts (continued)

Distributed by:JOHNSON & JOHNSON CONSUMER INC.McNeil Consumer Healthcare DivisionFort Washington, PA 19034 USA©J&JCI 2016www.imodium.com U.S. Patent No. 6,103,260

ask a doctor children 2-5 years (34 to 47 lbs)

do not use children under 2 years (up to 33 lbs)

Inactive ingredients acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, lavor, microcrystalline cellulose, stearic acid

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions ■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea■ take only on an empty stomach (1 hour before or 2 hours after a meal)■ take with a full (8 oz.) glass of water■ find right dose on chart. f possible, use weight to dose; otherwise, use age.

Drug Facts (continued)

0000

0000

00000000

00000000

LOT:

EXP.

Reference ID: 4083274

42 Caplets*42 Caplets*

NDC 50580 338 42

Multi-Symptom Relief

Loperamide HCI, 2 mg/Simethicone, 125 mgAntidiarrheal/Anti-gas

®

*capsule shaped tablets

LOT:

EXP:ever had a ash o o her a le gic reaction to lope am de HCl. Heart alert: Taking more han directed can ause serious heart p oblems o dea h. Do not use • f you have bloody or black stool • f you have difficulty swallowing. Ask a doctor befo e use if ou have • fever • mu us in he stool • a history of live disease.

Acti e ing edients (in ea h caplet) PurposesLope amide HCl 2 mg.. .... .... .... .... ... ... Anti diar healSimethi one 25 mg... .... .... .... .... .... ... .... ...Anti gasUses relieves symptoms of diar hea plus bloating, p essure and c amps, ommonly referred to as gasWarnings: Alle gy alert: Do not use f you have

Ask a doctor or pharmacist before use f you a e taking ant bioti s. When using his p oduct tiredness, d owsiness or dizziness may occur. Be careful when driving or ope ating machinery. Stop use and ask a doctor f • symptoms get wo se • diar hea lasts fo more han 2 days • you get abdominal swe ling o bulging. These may

be signs of a serious ond tion. • you have d fficulty swa lowing he caplet. If p egnant or b east-feeding, ask a heal h p ofessional before use. Keep out of each of chi d en. In ase of ove dose, get medica help or contact a Poison Cont ol Center right away. (1 800 222- 222) Directions • drink plenty of clear flu ds to help p event dehydration caused by diar hea • take only on an empty stoma h (1 hour before or 2 hou s after a meal) • take wi h a full (8 oz.) glass of water • If poss ble, use weight to dose; o herwise, use age. Adu ts and chi d en 12 yea s and o er: 2 aplets after he i st loose stool; 1 caplet after ea h subsequent loose stool; but no more han 4 caplets in 24 hou s. Chi d en 9-11 yea s (60-95 lbs): 1 aplet after he fi st loose stool; 1/2 caplet after ea h subsequent loose stool; but no more han 3 aplets in 24 hou s. Chi d en 6-8 years (48-59 lbs): 1 caplet after the fi st loose stool; 1/2 caplet after ea h subsequent loose stool; but no more han 2 caplets in 24 hou s. Chi dren 2-5 years (34 to 47 lbs) ask a doctor. Chi dren under 2 years (up to 33 lbs) do not useOther information • each caplet contains calcium 165 mg, sodium 3 mg • store between 20 25°C (68-77°F). P otect f om light. • do not use if printed foil seal on bottle is b oken or missing Questions or comments? ca l 1-877-895-3665 (toll-free) or 215-273-8755 ( ollect)Distributed by JOHNSON & JOHNSON CONSUMER INC.McNe l Consumer Healthcare Division, Fort Washington, PA 19034 USA ©J&JCI 2016www.imodium.com U S Patent No 6,103,260

00000000

Reference ID: 4083274

Multi-Symptom Relief30 Caplets

Loperamide HCI, 2 mg/Simethicone, 125 mg Antidiarrheal/Anti-gas

How

can we help?

1-877-8

95-3

66

5

Multi-Symptom ReliefCaplet

NDC 50580-338-42

Loperamide HCI, 2 mg/Simethicone, 125 mg Antidiarrheal/Anti-gas

®

®

See New Warning and Directions

• Cramps & Pressure• Bloating • Gas

Relieves symptomsof diarrhea plus

Actual Size

42 Caplets*

*capsule-shaped tablets

®

Other information ■ each caplet contains: calcium 165 mg, sodium 3 mg ■ store between 20-25°C (68-77°F). Protect from ight. ■ do not use if carton is open or if printed foil seal under bottle cap is open or torn

Drug Facts (continued)

Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Drug Facts (continued)

Distributed by:JOHNSON & JOHNSON CONSUMER INC.McNeil Consumer Healthcare DivisionFort Washington, PA 19034 USA©J&JCI 2016www.imodium.com U.S. Patent No. 6,103,260

ask a doctor children 2-5 years (34 to 47 bs)

do not use children under 2 years (up to 33 bs)

Inactive ingredients acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, lavor, microcrystalline cellulose, stearic acid

Do not use ■ if you have bloody or black stool ■ if you have dfficulty swallowingAsk a doctor before use if you have ■ fever ■ mucus in the stool ■ a history of liver disease

Stop use and ask a doctor if ■ symptoms get worse■ diarrhea lasts for more than 2 days ■ you get abdominal swelling or bulging. These may be signs of a serious condition.■ you have dfficulty swallowing the caplet

Ask a doctor or pharmacist before use if you are taking antbioticsWhen using this product tiredness, drowsiness or dizziness may occur Be careful when driving or operating machinery.

2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours

adults and children 12 yearsand overchildren9-11 years(60-95 lbs)

children6-8 years (48-59 bs)

WarningsAllergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HClHeart alert: Taking more than directed can cause serious heart problems or death

Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Active ingredients Purposes(in each caplet)Loperamide HCl 2 mg………............Anti-diarrhealSimethicone 125 mg…....….....................Anti-gas

Drug FactsDrug Facts (continued)

Drug Facts (continued)If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions ■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea■ take only on an empty stomach (1 hour before or 2 hours after a meal)■ take with a full (8 oz.) glass of water■ find right dose on chart. f possible, use weight to dose; otherwise, use age.

Drug Facts (continued)

0000

0000

/000

000

000000

000000

Reference ID: 4083274

42 Caplets*42 Caplets*

NDC 50580 338 42

Multi-Symptom Relief

Loperamide HCI, 2 mg/Simethicone, 125 mgAntidiarrheal/Anti-gas

®

*capsule shaped tablets

Direc ions • drink plenty of clear fluids to help prevent dehydration caused by diarrhea • take only on an empty stoma h (1 hour before or 2 hou s after a meal) • take w h a full (8 oz.) glass of water • find right dose on chart. If possible, use weight to dose; o herwise, use age.

1 caplet after he i st loose stool; /2 caplet after each subsequent loose stool; but no more han 3 caplets in 24 hou s

hi d en 9-11 yea s (60 95 bs)

adu ts and hi d en 2 yea s and over

2 caple s after he f rst oose s ool; 1 caplet a ter each subsequent loose stool; but no more han 4 aplets in 24 hou s

1 caplet after he i st loose stool; /2 caplet after each subsequent loose stool; but no more han 2 caplets in 24 hou s

hi d en 6-8 yea s (48 59 bs)

ask a doctorhi d en 2 5 yea s (34 to 47 lbs)

do not usehi d en under 2 yea s (up to 33 lbs)

Active ingredients (in each caplet) PurposesLope amide HCl 2 mg...... ...... ....... ...... ....... ...... ........ Anti diarrhealSime hicone 125 mg...... ....... ...... ....... ...... ....... ...... ....... ... Anti gasUses re ieves symptoms of diar hea plus bloating, pressure and c amps, commonly referred to as gasWarn ngs: Allergy alert: Do not use if you have ever had a ash or o her alle gic reaction to lope amide HCl. Heart alert Taking more han directed an ause serious heart problems or dea h. Do not

use • if you have bloody or black stool • if you have d f icu ty swallowing. Ask a doctor befo e use if you ha e • fever • mu us in he stool • a history of liver disease. Ask a doctor or pharmacist before use if you are taking ant biotics. When using his

p oduct tiredness, drowsiness or dizziness may occur. Be areful when driving or ope ating ma hinery. Stop use and ask a doctor if symptoms get worse • diar hea lasts for more han 2 days • you get abdominal swel ing or bulging. These may be signs of a serious cond tion. • you have d fficulty swallowing he caplet. If pregnant or b east-feeding, ask a heal h professional before use. Keep out of each of chi dren. In case of overdose, get medica help or contact a Poison Control Center right away. (1 800 222- 222)

O her informa ion • each caplet contains: calcium 165 mg, sodium 3 mg • store between 20 25°C (68-77°F). Protect from ight. • do not use if printed foil seal on bottle is broken or missingQues ions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Distributed by: JOHNSON & JOHNSON CONSUMER INC.

McNeil Consumer Healthcare DivisionFort W

ashington, PA 19034 USA ©J&JCI 2016 US6,103,26000000000

000000

EX

P. LO

T:

Reference ID: 4083274

---------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically and this page is the manifestation of the electronicsignature.---------------------------------------------------------------------------------------------------------/s/----------------------------------------------------

VALERIE S PRATT04/12/2017

Reference ID: 4083274