PEPTO DIARRHEA- bismuth subsalicylate suspension 
The Procter & Gamble Manufacturing Company

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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 Product03/01/201906/30/2026
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00803/01/201806/30/2026
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 11/2023
 
The Procter & Gamble Manufacturing Company