Label: PEPTO BISMOL CHEWABLES- bismuth subsalicylate tablet, chewable

  • NDC Code(s): 58933-013-02, 58933-013-04, 58933-013-12
  • Packager: Procter & Gamble Manufactura S de RL de CV
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 10, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Bismuth subsalicylate 262 mg

  • Active ingredient (in each tablet) 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

    • chew or dissolve in mouth
    • adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea
    • 2 tablets (1 dose) every ½ hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea)
    • 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
  • Other information

    • each tablet contains:calcium 140 mg, magnesium 9 mg
    • salicylate 99 mg
    • low sodium
    • avoid excessive heat (over 104°F or 40°C)
  • Inactive ingredients

    adipic acid, calcium carbonate, D&C Red No. 27 aluminum lake, FD&C Red No. 40 aluminum lake, flavor, magnesium stearate, mannitol, povidone, saccharin sodium, talc

  • Questions?

    1-800-717-3786

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: Do not use if the printed inner wrap is broken or missing.

  • SPL UNCLASSIFIED SECTION

    MADE IN MEXICO

    DIST. BY PROCTER & GAMBLE

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 30 Tablet Carton

    Pepto
    Bismol     ®


    Bismuth Subsalicylate
    Upset Stomach Reliever/ Antidiarrheal


    CHEWABLES


    CHERRY


    5 SYMPTOM

    RELIEF


    NAUSEA
    HEARTBURN
    INDIGESTION
    UPSET STOMACH
    DIARRHEA

    30 CHEWABLE TABLETS

    018

  • INGREDIENTS AND APPEARANCE
    PEPTO BISMOL  CHEWABLES
    bismuth subsalicylate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58933-013
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE525 mg  in 2 
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize16mm
    FlavorCHERRYImprint Code Pepto;Bismol
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58933-013-022 in 1 CELLO PACK; Type 0: Not a Combination Product06/30/2004
    2NDC:58933-013-045 in 1 CARTON06/30/2004
    26 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:58933-013-125959 in 1 BAG; Type 0: Not a Combination Product06/30/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00806/30/2004
    Labeler - Procter & Gamble Manufactura S de RL de CV (812807550)
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