Label: PEPTO-BISMOL- bismuth subsalicylate tablet

  • 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 July 25, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each tablet)

    Bismuth subsalicylate 262 mg

  • Purposes

    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

    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

    ● 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

  • Other information

    ● each tablet contains: calcium 140 mg, magnesium 9 mg

    ● salicylate 101 mg ● very low sodium

    ● avoid excessive heat (over 104°F or 40°C)

  • Inactive ingredients

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

  • Questions?

    1-800-717-3786

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    PEPTO-BISMOL 
    bismuth subsalicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73097-010(NDC:58933-477)
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize16mm
    FlavorWINTERGREENImprint Code Pepto;Bismol
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73097-010-4020 in 1 CARTON07/15/2019
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:73097-010-022 in 1 POUCH; Type 0: Not a Combination Product07/15/2019
    3NDC:73097-010-5025 in 1 CARTON07/15/2019
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33507/15/2019
    Labeler - Savings Distributors LLC (010527359)
    Establishment
    NameAddressID/FEIBusiness Operations
    Savings Distributors LLC010527359repack(73097-010)
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