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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 21, 2017

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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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