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

  • 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 02/13

If you are a consumer or patient please visit this version.

  • Active ingredient (in each softgel)

    Simethicone 125 mg

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  • Purpose

    Antiflatulent (Antigas)

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  • Uses

    • relieves bloating, pressure, or fullness commonly referred to as gas
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  • Warnings

    Stop use and ask a doctor if

    condition persists.

    If pregnant or breast- feeding

     ask a health care professional before use.

    Keep out of reach of children

     In case of overdose, get medical help or contact a Poison Control Center right away

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  • Directions

    • adults: swallow with water 1 or 2 softgels as needed after meals and 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 15o- 30o C (59o- 86o F)
    • protect from heat and moisture
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  • Inactive ingredients

    D&C yellow #10, edible ink, FD&C Blue#1, FD&C Red#40, gelatin, glycerin, peppermint oil, purified water, sorbitol special, and titanium dioxide

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  • Questions or Comments?

    1-800-616-2471

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  • Principal Display Panel

     MAJOR® 

    Gas Free

    Extra Strength Gas Relief

    ANTIGAS

    SIMETHICONE 125 mg

    Relieves:

    • bloating
    • pressure
    • fullness
    • gas

    *Compare to the active ingredient in Extra Strength Gas-X®

    *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Extra Strength Gas-X®

    Distributed by:

    Major® Pharmaceuticals

    31778 Enterprise Drive

    Livonia MI 48150 USA

    EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

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  • Product Label

    Major Pharmaceuticals

    Simethicone 125 mg softgels

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  • INGREDIENTS AND APPEARANCE
    MAJOR EXTRA STRENGTH GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0904-5458
    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
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    GELATIN  
    GLYCERIN  
    PEPPERMINT OIL  
    TITANIUM DIOXIDE  
    WATER  
    SORBITOL  
    Product Characteristics
    Color GREEN Score no score
    Shape OVAL Size 10mm
    Flavor Imprint Code PO
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-5458-46 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part332 09/16/1998
    Labeler - Major Pharmaceuticals (191427277)
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