Label: ANTIFLATULENT- simethicone tablet, chewable

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

Drug Label Information

Updated December 4, 2024

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  • ACTIVE INGREDIENT(in each tablet)

    Simethicone 80 mg

  • PURPOSE

    Antigas

  • USE(S)

    relieves:


    • pressure
    • bloating
    • symptoms referred to as gas
  • WARNINGS

    .

  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. 

  • DIRECTIONS

    • chew 2 to 4 tablets thoroughly as needed after meals and at bedtime
    • do not exceed 6 tablets per day unless directed by a physician
  • OTHER INFORMATION

    • do not use if inner seal is broken
    • store at room temperature
    • avoid high humidity and excessive heat, above 40oC (104oF)
  • INACTIVE INGREDIENTS

    compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

  • QUESTIONS

    Call (800) 616-2471

  • PRINCIPAL DISPLAY PANEL

    NDC 0904-7206-60
    MAJOR
    Simethicone 80 mg

    Antiflatulent

    Relieves gas pain, pressure and bloating

    100 Chewable Tablets

    98

    98

  • INGREDIENTS AND APPEARANCE
    ANTIFLATULENT 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7206
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUGARCANE (UNII: 81H2R5AOH3)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize13mm
    FlavorPEPPERMINTImprint Code G;103
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-7206-60100 in 1 BOTTLE; Type 0: Not a Combination Product10/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00210/04/2021
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guardian Drug Company119210276MANUFACTURE(0904-7206)
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