MAJOR ULTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]

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MAJOR ULTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]
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NDC 0904-5572-52
Set ID f4f64a21-98ae-410d-add2-8eb3e6be2302
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART332
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  • 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 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • 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

    17177 N Laurel Park Drive,Suite 233

    Livonia, MI 48152

    TAMPER EVIDENT: DO NOT USE IF PRINTED 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

  • INGREDIENTS AND APPEARANCE
    MAJOR ULTRA STRENGTH GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5572
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code S180
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-5572-5260 in 1 BOTTLE; Type 0: Not a Combination Product07/12/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33207/12/2010
    Labeler - Major Pharmaceuticals (191427277)
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