Label: GAS RELIEF EXTRA STRENGTH- dimethicone capsule, liquid filled 

  • Label RSS
  • NDC Code(s): 76270-103-03
  • Packager: PuraVation Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/13

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  • Active ingredient (in each softgel)

    Simethicone 125 mg

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  • Purpose

    Antigas

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  • Uses for relief of:

    • pressure, bloating, and fullness commonly refered to as gas
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  • Warnings

    Keep out of reach of children.

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  • Directions

    • adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime
    • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
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  • Other information

    • store at room temperature 15°-30°C (59°-86°F)
    • protect from light, heat and moisture
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  • Inactive ingredients

    D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, white edible ink

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  • Questions or comments?

    Report serious side effects to PuraVation Pharmaceutical Inc, 1001 Durham Avenue, Suite 300, South Plainfield, NJ 07080

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  • PRINCIPAL DISPLAY PANEL - Shipping Label

    EXTRA STRENGTH

    Gas Relief

    NDC # 76270-103-03

    *Compare to the active ingredient in EXTRA STRENGTH GAS-X®

    Simethicone 125 mg

    Antigas

    Relieves Gas

    • Bloating
    • Pressure
    • Fullness

    15 SOFTGELS (125 mg each)

     

     PRINCIPAL DISPLAY PANEL - Shipping Label

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  • INGREDIENTS AND APPEARANCE
    GAS RELIEF EXTRA STRENGTH 
    simethicone capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76270-103
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 125 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    D&C YELLOW NO. 10  
    GELATIN  
    GLYCERIN  
    PEPPERMINT OIL  
    WATER  
    Product Characteristics
    Color green Score no score
    Shape CAPSULE (OVAL) Size 9mm
    Flavor Imprint Code PC2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76270-103-03 1 in 1 CARTON
    1 15 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part332 09/15/2013
    Labeler - PuraVation Pharmaceuticals Inc (968385034)
    Establishment
    Name Address ID/FEI Business Operations
    Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 421293287 MANUFACTURE(76270-103), ANALYSIS(76270-103)
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