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

  • 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 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 finalpart33504/28/2003
    Labeler - Marc Glassman, Inc. (094487477)