Label: ANTIFLATULENT- simethicone 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 June 17, 2022

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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)
  • HOW SUPPLIED

    Simethicone Chewable Tablets, 80 mg are white, round, tablets, debossed with "G and 103" on one side and are supplied as:

    NDC 0904-7206-60 in bottle of 100 chewable tablets

    Distributed by:

    Major Pharmaceuticals

    Livonia, MI 48152

  • INACTIVE INGREDIENTS

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

  • QUESTIONS

    Call (800) 616-2471

  • Repackaging Information

    Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

    Count80 mg
    471610-650-04

    Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

    Repackaged by:
    Aphena Pharma Solutions - TN
    Cookeville, TN 38506

    20220519JK

  • PRINCIPAL DISPLAY PANEL - 80 mg

    NDC 71610-650 - Simethicone 80 mg Chewable Tablet - Rx Only
    Bottle Label 80 mg

  • INGREDIENTS AND APPEARANCE
    ANTIFLATULENT 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71610-650(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:71610-650-044 in 1 BOTTLE; Type 0: Not a Combination Product05/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33210/04/2021
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(71610-650)
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