Label: PEPTO-BISMOL- bismuth subsalicylate liquid

  • NDC Code(s): 37000-475-08, 37000-475-12, 37000-475-16
  • 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 October 27, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each 30mL dose cup)

    Bismuth subsalicylate 525 mg

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  • Purposes

    Upset stomach reliever and antidiarrheal

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  • Uses

    relieves

    • travelers' diarrhea
    • diarrhea
    • upset stomach due to overindulgence in food and drink, including:
      • heartburn
      • indigestion
      • nausea
      • gas
      • belching
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  • 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.

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  • Directions

    • shake well before use
    • for accurate dosing, use dose cup or tablespoon (TBSP)
    • adults and children 12 years and over:

      1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour as needed
    • do not exceed 8 doses (240 mL or 16 TBSP) 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
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  • Other information

    • each 30 mL contains: magnesium 25mg, sodium 8 mg
    • salicylate 236 mg
    • low sodium
    • protect from freezing
    • avoid excessive heat (over 104°F or 40°C)
    • TAMPER EVIDENT: Do not use if imprinted shrinkband is missing or broken.
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  • Inactive ingredients

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

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  • Questions?

    1-800-717-3786

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  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble,
    Cincinnati OH 45202

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  • PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

    NDC 37000-475-08

    Pepto-
    BISMOLâ„¢

    BISMUTH SUBSALICYLATE
    UPSET STOMACH RELIEVER / ANTIDIARRHEAL

    5 SYMPTOM

    Digestive Relief

    • heartburn
    • indigestion
    • nausea
    • upset stomach
    • diarrhea

    CHERRY

    8 FL OZ (236 mL)

    475

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  • INGREDIENTS AND APPEARANCE
    PEPTO-BISMOL 
    bismuth subsalicylate liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-475
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 525 mg  in 30 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    D&C RED NO. 22 (UNII: 1678RKX8RT)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    SORBIC ACID (UNII: X045WJ989B)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color pink Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-475-08 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2004
    2 NDC:37000-475-12 354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2004
    3 NDC:37000-475-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2004
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part335 06/30/2004
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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