how can we help? 1-877-895-3665 · 1-877-895-3665, as ... (34 to 47 bs) do not use children under 2...
TRANSCRIPT
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
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ivisio
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n, P
A 19
034
USA
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JCI 2
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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
00
LOT
EX
P
NDC 50580-338-12
00000000
00000000
00000000
Reference ID: 4083274
Dis
tribu
ted
by:
JOH
NS
ON
& J
OH
NS
ON
C
ON
SU
ME
R IN
C.
McN
eil C
onsu
mer
Hea
lthca
re D
ivis
ion
Fort
Was
hing
ton,
PA
1903
4 U
SA
©J&
JCI 2
016
ww
w.im
odiu
m.c
omU
.S. P
aten
t No.
6,1
03,2
60
®
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
: E
XP
:
00000000
NDC 50580-338-18
00000000 0
0000000
00000000
30045-0212-184
TEAR OFF A SECTIO
N1
FOLD CO
RNER INW
ARDAN
D PEEL BACK FOIL
2
Reference ID: 4083274
Dis
tribu
ted
by:
JOH
NS
ON
& J
OH
NS
ON
C
ON
SU
ME
R IN
C.
McN
eil C
onsu
mer
Hea
lthca
re D
ivis
ion
Fort
Was
hing
ton,
PA
1903
4 U
SA
©J&
JCI 2
016
ww
w.im
odiu
m.c
omU
.S. P
aten
t No.
6,1
03,2
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
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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)
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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