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
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated August 11, 2022

If you are a consumer or patient please visit this version.

  • 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

    P epto

    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 (1500 MPA.S) (UNII: P0NTE48364)  
    GELLAN GUM (HIGH ACYL) (UNII: W1L7G7ROMD)  
    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 finalpart33503/01/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)