Label: PEPTO-BISMOL- bismuth subsalicylate suspension

  • NDC Code(s): 37000-438-04, 37000-438-08, 37000-438-12, 37000-438-16, view more
    37000-438-24, 37000-438-32, 37000-438-34
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 30 mL dose)

    Bismuth subsalicylate 525 mg

  • Purpose

    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
    • only use dose cup provided
    • adults and children 12 years and over:
    • 30 mL (1 dose) every ½ hour or 60 mL (2 doses) every hour as needed for diarrhea/traveler's diarrhea
    • 30mL (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
    • do not exceed 8 doses (240 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 30 mL dose contains: magnesium 3 mg, sodium 4 mg
      • salicylate 261 mg
      • low sodium
      • protect from freezing
      • avoid excessive heat (over 104°F or 40°C)
    • TAMPER EVIDENT: Do not use if printed shrinkband is missing or broken.
  • 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

    DIST. BY PROCTER & GAMBLE,
    CINCINNATI OH 45202

  • PRINCIPAL DISPLAY PANEL - 354 mL Bottle Label

    Pepto

    Bismol®

    Bismuth Subsalicylate
    Upset Stomach Reliever/
    Antidiarrheal


    5 SYMPTOM

    RELIEF

    NAUSEA
    HEARTBURN
    INDIGESTION
    UPSET STOMACH
    DIARRHEA

    12 FL OZ (354 mL)

    438

  • INGREDIENTS AND APPEARANCE
    PEPTO-BISMOL 
    bismuth subsalicylate suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-438
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ, BISMUTH CATION - UNII:ZS9CD1I8YE) 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)  
    METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-438-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
    2NDC:37000-438-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
    3NDC:37000-438-12354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
    4NDC:37000-438-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
    5NDC:37000-438-242 in 1 CELLO PACK03/01/2018
    5354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:37000-438-322 in 1 CELLO PACK03/01/2018
    6473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:37000-438-34100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00803/01/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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