Label: MI-ACID GAS RELIEF- simethicone tablet, chewable

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

Drug Label Information

Updated June 20, 2024

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  • Active ingredient (in each tablet)

    Simethicone 80 mg

  • Purpose

    Antigas

  • KEEP OUT OF REACH OF CHILDREN

  • Uses

    relieves:

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

    Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center 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 40 0C (104 0F)
  • Inactive ingredients

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

  • Questions or comments?

    Call (800) 616-2471

  • PDP

    PDP

  • INGREDIENTS AND APPEARANCE
    MI-ACID GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-5136(NDC:0904-5068)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize13mm
    FlavorPEPPERMINTImprint Code GDC103
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-5136-330 in 1 BOTTLE; Type 0: Not a Combination Product12/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02203/02/2011
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300repack(68071-5136)
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