Pepto-Bismol ®

Drug Labeling and Warnings

Drug Details [pdf]

PEPTO-BISMOL- bismuth subsalicylate suspension 
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.

----------

Pepto-Bismol ®

Drug Facts

Active Ingredient

in each 30 mL dose cup

Bismuth subsalicylate 525 mg

Purposes

Upset stomach reliever and antidiarrheal

Uses

relieves

• traveler's 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

• shake well before use
• use dose cup or tablespoon (TBSP)
• adults and children 12 years and over:
  
  1 dose (30 ml or 2 Tbsp) every 1/2 to 1 hour as needed
• do not exceed 8 doses (240 ml or 16 Tbsp) 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 Tbsp contains: magnesium 25 mg, sodium 8 mg
  • salicylate 261 mg
  • low sodium
  • protect from freezing
  • avoid excessive heat (over 104°F or 40°C)
• TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken.

Inactive ingredients

benzoic acid, flavor, magnesium aluminum silicate, methylcellulose, red 22, red 28, saccharin sodium, salicylic acid, sodium salicylate, sorbic acid, water

Questions?

1-800-717-3786

Dist. by Procter & Gamble,
Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

NDC: 37000-032-03

Pepto-

Bismol ®

BISMUTH SUBSALICYLATE

UPSET STOMACH RELIEVER/ANTIDIARRHEAL

5 Symptom Digestive Relief

• heartburn
• indigestion
• nausea
• upset Stomach
• diarrhea

12 FL OZ (354 mL)

PEPTO-BISMOL 
bismuth subsalicylate suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-032
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE)	BISMUTH SUBSALICYLATE	525 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SODIUM SALICYLATE (UNII: WIQ1H85SYP)
SORBIC ACID (UNII: X045WJ989B)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-032-01	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/31/1989	10/10/2019
2	NDC: 37000-032-02	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/31/1989	10/10/2019
3	NDC: 37000-032-03	354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/31/1989	10/10/2019
4	NDC: 37000-032-04	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/31/1989	10/10/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part335	03/31/1989	10/10/2019

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 3/2018

Document Id: 6739d388-5325-4da8-e053-2991aa0aca5b

34390-5

Set id: f2ed9662-687a-4091-b097-dec865af09aa

Version: 5

Effective Time: 20180312

 

The Pr