Label: PEPTO-BISMOL- bismuth subsalicylate tablet, chewable 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each tablet)

    Bismuth subsalicylate 262 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
      • fullness
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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

    • chew or dissolve in mouth
    • adults and children 12 years and over: 2 tablets every 1/2 to 1 hour as needed
    • do not exceed 8 doses (16 tablets) 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 tablet contains: calcium 140 mg
    • sodium less than 1 mg
    • salicylate 102 mg
    • very low sodium
    • sugar free
    • avoid excessive heat (over 104°F or 40°C)
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  • Inactive ingredients

    calcium carbonate, flavor, magnesium stearate, mannitol, povidone, red 27 aluminum lake, saccharin sodium, talc

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  • Questions?

    1-800-717-3786

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  • SPL UNCLASSIFIED SECTION

    Repackaged and distributed with
    permission of manufacturer by:

    Lil' Drug Store Products
    1201 Continental Place NE
    Cedar Rapids, IA 52402

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  • PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton

    Pepto
    BISMOL™

    BISMUTH SUBSALICYLATE
    UPSET STOMACH RELIEVER/ANTIDIARRHEAL

    5 SYMPTOM RELIEF

    Nausea • Heartburn • Indigestion
    Upset Stomach • Diarrhea

    4 CHEWABLE
    TABLETS

    Lil'
    DrugStore®

    Principal Display Panel - 4 Tablet Pouch Carton
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  • INGREDIENTS AND APPEARANCE
    PEPTO-BISMOL 
    bismuth subsalicylate tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66715-9723(NDC:37000-477)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Bismuth subsalicylate (Bismuth cation) Bismuth subsalicylate 262 mg
    Inactive Ingredients
    Ingredient Name Strength
    calcium carbonate  
    magnesium stearate  
    mannitol  
    povidones  
    D&C red no. 27  
    aluminum oxide  
    saccharin sodium  
    talc  
    Product Characteristics
    Color PINK Score no score
    Shape ROUND Size 16mm
    Flavor Imprint Code Pepto;Bismol
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66715-9723-2 2 in 1 CARTON
    1 2 in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part335 09/16/2010
    Labeler - Lil' Drug Store Products, Inc. (093103646)
    Establishment
    Name Address ID/FEI Business Operations
    CCB Packaging Inc. 362374464 REPACK(66715-9723), RELABEL(66715-9723)
    Establishment
    Name Address ID/FEI Business Operations
    The Proctor & Gamble Manufacturing Company 007130032 MANUFACTURE(66715-9723)
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