PEPTO DIARRHEA- 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.

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Pepto® Diarrhea

Drug Facts

Active ingredient (in each 10 mL dose)

Bismuth subsalicylate 525 mg

Purpose

Antidiarrheal

Uses

relieves

  • travelers' diarrhea
  • diarrhea

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
  • 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
  • adults and children 12 years and over:
  • 10 mL (1 dose) every ½ hour to 1 hour or 20 mL (2 doses) every hour as needed for diarrhea/travelers’ diarrhea
  • do not exceed 8 doses (80 mL) 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 10 mL dose contains: salicylate 212 mg
    • low sodium
    • store at no greater than 30°C
    • protect from freezing
    • avoid excessive heat (over 104°F or 40°C)

Inactive ingredients

benzoic acid, D&C Red No. 22, D&C Red No. 28, flavor, gellan gum, magnesium aluminum silicate, methylcellulose, salicylic acid, sodium salicylate, sorbic acid, sucralose, water

Questions?

1-800-717-3786

Tamper Evident: Do not use if printed shrinkband
seal around the neck is broken or missing

DIST. BY PROCTER & GAMBLE,
CINCINNATI OH 45202

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

*vs. Original Pepto Bismol®

Pepto®

Diarrhea

Bismuth Subsalicylate

Antidiarrheal

CHERRY

COATS & KILLS BACTERIA THAT CAUSE DIARRHEA

4 FL OZ

(118 mL)

538

PEPTO  DIARRHEA
bismuth subsalicylate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-538
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
D&C RED NO. 22 (UNII: 1678RKX8RT)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
SORBIC ACID (UNII: X045WJ989B)  
WATER (UNII: 059QF0KO0R)  
GELLAN GUM (HIGH ACYL) (UNII: W1L7G7ROMD)  
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37000-538-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00803/01/2018
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 8/2023
Document Id: 030e31f6-dad7-5998-e063-6294a90af43a
Set id: 8517edac-fda7-7a49-e053-2a91aa0a24cd
Version: 6
Effective Time: 20230816
 
The Procter & Gamble Manufacturing Company