Label: BISMUTH CHEWABLE- bismuth subsalicylate 262 mg tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2016

If you are a consumer or patient please visit this version.

  • Active ingredient

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

  • Purpose

    Antidiarrheal/Antacid

  • Uses

    ■ controls diarrhea   

    ■ relieves heartburn, indigestion, nausea and upset stomach

  • 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

    ■ bloody or black stool  

    ■ an ulcer 

    ■ a bleeding problem

    Ask a doctor before use if you have

    ■ fever   

    ■ mucus in the stool

    Ask a doctor or pharmacist before use if

    you are taking a drug for  

    ■ anticoagulation (thinning of 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  

    ■ ringing in the ears or loss of hearing occurs  

    ■ diarrhea lasts for more than 2 days

    Pregnancy/Breastfeeding

    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) immediately.

  • Directions

    ■ drink plenty of clear fluids to help revent deydration caused by diarrhea 

    ■ Adults and children 12 years and over: 2 tablets every ½ to 1 hour or 4 tablets every hour as needed

    ■ do not exceed 16 tablets in 24 hours  

    ■ use until diarrhea stops but no more than 2 days 

    ■ Children under 12 years of age: ask a doctor

  • Other information

    ■ Phenylketonurics: contains phenylalanine 1.1mg per tablet  

    ■ Calcium content per tablet: 73mg  

    ■ save carton for full directions and warnings   

    ■ store at room temperature  15°– 30°C (59°– 86°F)    

    ■ do not use if cellophane unit is torn

  • Inactive ingredients

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

  • Principal Display Panel

    Bismuth

    Bismuth

     

  • INGREDIENTS AND APPEARANCE
    BISMUTH CHEWABLE 
    bismuth subsalicylate 262 mg tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-046
    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
    ASPARTAME (UNII: Z0H242BBR1)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    DEXTRATES (UNII: G263MI44RU)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize17mm
    FlavorPEPPERMINTImprint Code RH;046
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-046-8830 in 1 CARTON04/28/2003
    11 in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00804/28/2003
    Labeler - Marc Glassman, Inc. (094487477)