Label: MI-ACID GAS RELIEF- 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 October 30, 2017

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  • Active ingredient (in each tablet)

    Simethicone 80 mg

  • Purpose

    Antigas

  • KEEP OUT OF REACH OF CHILDREN

    Enter section text here

  • Uses

    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 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 400C (1040F)
  • Inactive ingredients

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

  • Questions

    To Report Adverse Drug Event  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
    443353-325-04

    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

    20171030JH

  • PRINCIPAL DISPLAY PANEL - 80mg

    NDC 43353-325 Simethicone 80mg - Rx Only
    Bottle Label 80mg

  • INGREDIENTS AND APPEARANCE
    MI-ACID GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43353-325(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 (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:43353-325-044 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33203/02/2011
    Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC128385585REPACK(43353-325)
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