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MAJOR ULTRA STRENGTH GAS RELIEF (Major Pharmaceuticals)

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (0904-5572-52) Label Information

Complete MAJOR ULTRA STRENGTH GAS RELIEF Information

  • Active ingredient (in each softgel)

    Simethicone 180 mg


  • Purpose

    Antiflatulent (Antigas)


  • Uses

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

  • Warnings

    Stop use and ask a doctor if

    condition persists.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

  • Directions

    • swallow one or two softgels as needed after a meal
    • do not exceed two softgels per day except under the advice and supervision of a physician

  • Other information

    • store at 15º-30ºC (59º-86ºF)

  • Inactive ingredients

    edible ink, FD&C yellow #6, gelatin, glycerin, purified water


  • Questions or comments?

    Call 1-800-616-2471


  • Principal Display Panel

    Ultra Strength GAS RELIEF

    Antiflatulent

    Simethicone 180 mg

    Relieves Bloating, Pressure, Fullness & Gas

    *Compare to the active ingredient of PHAZYME® ULTRA STRENGTH

    Softgels

    *This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme®.

    Distributed by:

    MAJOR® PHARMACEUTICALS

    31778 Enterprise Drive

    Livonia, MI 48150, U.S.A.

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.


  • Product Label

    Simethicone 180 mg

    Major Ultra Strength Gas Relief Softgel


  • INGREDIENTS AND APPEARANCE
    MAJOR ULTRA STRENGTH GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-5572
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 180 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color ORANGE Score no score
    Shape OVAL Size 12mm
    Flavor Imprint Code S180
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-5572-52 60 in 1 BOTTLE; Type 0: Not a Combination Product 07/12/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part332 07/12/2010
    Labeler - Major Pharmaceuticals (191427277)