Label: PEPTO BISMOL FAST MELTS FRESH BERRY FLAVORED- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 69423-831-24
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 21, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each soft chewable tablet)

    Bismuth subsalicylate 262 mg

  • Purpose

    Upset stomach reliever and antidiarrheal

  • Uses

    relieves

    • travelers' 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
  • PREGNANCY OR BREAST FEEDING

    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

    • fully chew before swallowing
    • adults and children 12 years and over: 

        • 2 soft chewable tablets every 1/2 hour or 4 soft chewable tablets every hour as needed for diarrhea

        • 2 soft chewable tablets every 1/2 hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)

    • do not exceed 8 doses (16 soft chewable 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
  • Other information

    • each soft chewable tablet contains:  • calcium 55 mg  • salicylate 100 mg  • low sodium
    • Store at no greater than 25°C.  Avoid excessive heat (over 40°C).
  • Inactive ingredients

    calcium carbonate, carrageenan, corn syrup, FD&C Red No. 40, flavor, hydrogenated coconut oil, soy lecithin, sucrose, water

  • Questions?

    1-800-717-3786

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF INNER PRINTED SEAL ON BOTTLE IS BROKEN OR MISSING.

  • SPL UNCLASSIFIED SECTION

    DIST. BY: PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 24 SOFT CHEWABLE TABLETS

    Pepto Bismol®

    Bismuth Subsalicylate

    Upset Stomach Reliever/Antidiarrheal

    FAST MELTS

    5 SYMPTOM RELIEF

    FRESH BERRY FLAVORED

    24 SOFT CHEWABLE TABLETS

    831

    Add image transcription here...

  • INGREDIENTS AND APPEARANCE
    PEPTO BISMOL FAST MELTS  FRESH BERRY FLAVORED
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-831
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize22mm
    FlavorBERRYImprint Code C
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-831-2424 in 1 BOTTLE; Type 0: Not a Combination Product03/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00803/05/2024
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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