PEPTO BISMOL DIARRHEA LIQUICAPS- bismuth subsalicylate capsule, liquid filled

Pepto Bismol by

Drug Labeling and Warnings

Pepto Bismol by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each LiquiCap)

Bismuth subsalicylate 262 mg

Purpose

Upset stomach reliever and antidiarrheal

Uses

relieves

• travelers' diarrhea
• diarrhea
• upset stomach due to overindulgence in food and drink, including:
  heartburn
  indigestion
  nausea
  gas
  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

Questions?

1-800-717-3786

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MADE IN CANADA

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 48 LiquiCap Carton

P epto®

Diarrhea

Bismuth Subsalicylate

Antidiarrheal

LIQUICAPS

RELIEVES

DIARRHEA

48 LiquiCaps™

INGREDIENTS AND APPEARANCE

PEPTO BISMOL  DIARRHEA LIQUICAPS
bismuth subsalicylate capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-537
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ)	BISMUTH SUBSALICYLATE	262 mg

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GELATIN (UNII: 2G86QN327L)
POVIDONE (UNII: FZ989GH94E)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	PB
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-537-12	1 in 1 CARTON	03/01/2019
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 37000-537-24	2 in 1 CARTON	03/01/2019
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 37000-537-48	4 in 1 CARTON	03/01/2019
3		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	03/01/2018

Labeler - The Procter & Gamble Manufacturing Company (004238200)