Label: BISMUTH- bismuth subsalicylate tablet

  • NDC Code(s): 69168-046-32, 69168-046-69, 69168-046-88
  • Packager: Allegiant Health
  • 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 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33512/23/2014
    Labeler - Allegiant Health (079501930)
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