Label: BISMUTH- bismuth subsalicylate tablet

  • NDC Code(s): 69168-046-32, 69168-046-50, 69168-046-69, 69168-046-88
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 2018

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  • Active ingredient

    Bismuth subsalicylate 262 mg (each tablet contains 102 mg salicylate)

  • Purpose

    Antidiarrheal/Antacid

  • 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

    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  n diarrhea lasts more than 2 days

    When using this product

    a temporary, but harmless, darkening of the stool and/or tongue may occur

    If pregnant or breast-feeding

    ask a health professional before use.

  • Keep Out of Reach of Children

    In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away. 

  • Directions

    • chew or dissolve in mouth

    Adults and children over 12 years : 2 tablets (1 dose) every ½ hour or 4 tablets (2 doses) every hour as needed for diarrhea

    • 2 tablets (1 dose) every 1/2 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 no more than 2 days

    Children under 12 years of age: ask a doctor

    • drink plenty of clear fluids to prevent dehydration caused by diarrhea 
  • Inactive Ingredients

    acacia gum, aspartame, calcium carbonate, D&C red #27 aluminum lake, dextrates, magnesium stearate, maltodextrin, microcrystalline cellulose, peppermint flavor, silicon dioxide

  • Package/Label Principal Display Panel

    Bismuth

    Bismuth

  • INGREDIENTS AND APPEARANCE
    BISMUTH 
    bismuth subsalicylate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-046
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBSALICYLATE262 mg
    Inactive Ingredients
    Ingredient NameStrength
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DEXTRATES (UNII: G263MI44RU)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ACACIA (UNII: 5C5403N26O)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize17mm
    FlavorImprint Code RH046
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-046-6912 in 1 CELLO PACK; Type 0: Not a Combination Product12/23/2014
    2NDC:69168-046-8830 in 1 CELLO PACK; Type 0: Not a Combination Product12/23/2014
    3NDC:69168-046-32100 in 1 BOTTLE; Type 0: Not a Combination Product05/31/2023
    4NDC:69168-046-5050 in 1 BOTTLE; Type 0: Not a Combination Product11/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00812/23/2014
    Labeler - Allegiant Health (079501930)
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