Label: PEPTO DIARRHEA- bismuth subsalicylate suspension

  • NDC Code(s): 37000-538-04
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 28, 2023

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  • SPL UNCLASSIFIED SECTION

    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

    Keep out of reach of children.

  • OVERDOSAGE

    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

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    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

  • INGREDIENTS AND APPEARANCE
    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)
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