EXTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [GREENBRIER INTERNATIONAL, INC.]

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EXTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [GREENBRIER INTERNATIONAL, INC.]
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NDC 33992-3113-5
Set ID b50bc466-9fd3-457c-8c7b-526b17ff8d1a
Category HUMAN OTC DRUG LABEL
Packager Greenbrier International, Inc.
Generic Name
Product Class
Product Number
Application Number PART332
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  • Active ingredient (per each softgel)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Use

    for the relief of

    •
    Pressure, bloating, and fullness commonly referred to as gas
  • Warnings

    Keep out of reach of children.

  • 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.
  • Other information

    •
    store at room temperature
    •
    protect from light, heat, and moisture
  • Inactive ingredients

    D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide

    Questions or comments

    1-866-467-2748

  • Principal Display Panel

    Extra Strength Gas Relief Simeticone ,125 mg Anti-Gas 15 Softgels

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

    Assured

    Extra Strength

    Gas Relief

    SIMETHICONE, 125mg

    ANTI-GAS

    Relieves:

    •
    Bloating
    •
    Pressure
    •
    Fullness
    •
    Gas

    15 SOFTGELS

    *This product is not manufactured or distributed by GSK Consumer Healthcare, Inc., the distributor of Gas-X® Extra strength.

    Distributed by:

    Greenbrier International, Inc.

    Chesapeake, VA 23320

    IMPORTANT: Keep this carton for future reference on full labeling.

    DO NOT USE IF ANY INDIVIDUAL BLISTER IS BROKEN OR OPEN

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-3113
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREEN (Opaque) Scoreno score
    ShapeOVALSize10mm
    FlavorImprint Code PC2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-3113-51 in 1 CARTON01/19/2018
    115 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33201/19/2018
    Labeler - Greenbrier International, Inc. (610322518)
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