PEPTO BISMOL LIQUICAPS- bismuth subsalicylate capsule, liquid filled

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
The Procter & Gamble Manufacturing Company
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Upset stomach reliever and antidiarrheal relieves - travelers' diarrhea - diarrhea - upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness
Authorization status:
OTC monograph final
Authorization number:
37000-535-12, 37000-535-24, 37000-535-48

PEPTO BISMOL LIQUICAPS- bismuth subsalicylate capsule, liquid filled

The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Pepto Bismol ®

Diarrhea

Drug Facts

Active ingredient (in each LiquiCap)

Bismuth subsalicylate 262 mg

Purpos e

Upset stomach reliever and antidiarrheal

Us es

relieves

travelers' diarrhea

diarrhea

upset stomach due to overindulgence in food and drink, including:

heartburn

indigestion

nausea

belching

fullness

Warnings

Reye's syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not

use this product. When using this product, if changes in behavior with nausea and vomiting occur,

consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious

illness.

Allergy alert:

Contains salicylate .

Do not take if you are

allergic to salicylates (including aspirin)

taking other salicylate products

Do not use if you have

an ulcer

a bleeding problem

bloody or black stool

Ask a doctor before use if you have

fever

mucus in the stool

Ask a doctor or pharmacist before use if you are taking any drug for

anticoagulation (thinning the blood)

diabetes

gout

arthritis

When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

symptoms get worse or last more than 2 days

ringing in the ears or loss of hearing occurs

diarrhea lasts more than 2 days

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.

Directions

swallow with water, do not chew

adults and children 12 years and over:

2 LiquiCaps every ½ hour or 4 LiquiCaps every hour as needed for diarrhea

2 LiquiCaps every ½ hour to 1 hour as needed for overindulgence (upset stomach, heartburn,

indigestion, nausea)

do not exceed 8 doses (16 LiquiCaps) in 24 hours

use until diarrhea stops but not more than 2 days

children under 12 years: ask a doctor

drink plenty of clear fluids to help prevent dehydration caused by diarrhea

Other information

each LiquiCap contains:

salicylate 199 mg

low sodium

do not exceed 25°C

Inactive ingredients

D&C red No. 33, gelatin, glycerin, polyethylene glycol, pharmaceutical ink, polysorbate 20, povidone,

sorbitol sorbitan solution, titanium dioxide

Ques tions ?

1-800-717-3786

MADE IN CANADA

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 48 LiquiCap Carton

P epto

Bis mol®

Bismuth Subsalicylate

Upset Stomach Reliever/Antidiarrheal

LIQUICAPS

5 SYMPTOM RELIEF

NAUSEA

HEARTBURN

INDIGESTION

UPSET STOMACH

DIARRHEA

48 LiquiCaps™

PEPTO BISMOL LIQUICAPS

bismuth subsalicylate capsule, liquid filled

Product Information

The Procter & Gamble Manufacturing Company

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:370 0 0 -535

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BISMUTH SUBSALICYLATE (UNII: 6 2TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)

BISMUTH SUBSALICYLATE 26 2 mg

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

SO RBITO L (UNII: 50 6 T6 0 A25R)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

GELATIN (UNII: 2G8 6 QN327L)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

Product Characteristics

Color

pink

S core

no sco re

S hap e

CAPSULE

S iz e

14mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:370 0 0 -535-12

1 in 1 CARTON

0 3/0 1/20 19

1

12 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:370 0 0 -535-24

2 in 1 CARTON

0 3/0 1/20 19

2

12 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

3

NDC:370 0 0 -535-48

4 in 1 CARTON

0 3/0 1/20 19

3

12 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt335

0 3/0 1/20 18

Labeler -

T he Procter & Gamble Manufacturing Company (004238200)

Revised: 3/2019

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