Label: GNP REGULAR STRENGTH GAS RELIEF- dimethicone 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 May 19, 2022

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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 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

    DISTRIBUTED BY: 

    ATLANTIC BIOLOGICALS CORP.

    MIAMI, FL 33179

  • PDP

    NDC 17856-1118-1

    regular strength

    Gas Relief

    Anti-gas

    fast relief of: pressure, bloating & gas distress

    mint

    50 chewable tablets (80 mg ea.)

    image 1

  • INGREDIENTS AND APPEARANCE
    GNP REGULAR STRENGTH GAS RELIEF 
    dimethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-1118(NDC:24385-118)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
    Inactive Ingredients
    Ingredient NameStrength
    RAW SUGAR (UNII: 8M707QY5GH)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeCAPSULE (round tablet) Size13mm
    FlavorMINTImprint Code G103
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-1118-150 in 1 BOX04/21/2022
    1NDC:17856-1118-21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33208/08/2011
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTIONS360804194repack(17856-1118)
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