Label: GAS-X EXTRA STRENGTH SOFTGELS- simethicone capsule, liquid filled

  • NDC Code(s): 0067-6275-01, 0067-6275-10, 0067-6275-20, 0067-6275-30, view more
    0067-6275-50, 0067-6275-72, 0067-6275-82
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • 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 November 17, 2021

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  • Active ingredient (in each softgel)

    Simethicone 125mg

  • Purpose

    Antigas

  • Use

    for the relief of

    •
    pressure, bloating, and fullness commonly referred to as gas
  • Warning

    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 controlled room temperature 20-25ºC (68-77ºF)
    •
    protect from light, heat, and moisture
  • Inactive ingredients

    D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, hypromellose, peppermint oil, sorbitan, sorbitol, titanium dioxide

  • Questions or comments?

    call 1-800-452-0051

  • Principal Display Panel

    #1 DOCTOR RECOMMENDED BRAND

    NDC 0067-6275-10

    Gas-X®

    SIMETHICONE 125 MG / ANTIGAS

    RELIEVES GAS FAST

    PRESSURE – BLOATING – DISCOMFORT

    EXTRA STRENGTH

    10 SOFTGELS

    Gas-X® Extra Strength Softgels are concentrated to contain liquid gas-fighting medicine in a small softgels so they are easy to swallow, and there is no chalky taste.

    TAMPER EVIDENT FEATURE:

    Gas-X® Extra Strength Softgels are sealed in blister packets. Use only of the individual seal is unbroken.

    Gas-X® Extra Strength Softgels offer fast, effective relief of pressure and bloating that antacids can’t provide. They are specially formulated with simethicone, the antigas medicine doctors recommend most for pressure, bloating, or discomfort referred to as gas.

    1-800-452-0051

    www.Gas-X.com

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    Trademarks are owned by or licensed to the GSK group of companies. ©2016 GSK group of companies or its licensor. All rights reserved.

    46177349

    46177349_Gas-X Extra Strength Softgels_10 ct.JPG
  • INGREDIENTS AND APPEARANCE
    GAS-X  EXTRA STRENGTH SOFTGELS
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6275
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code G;X
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-6275-303 in 1 CARTON09/12/2011
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0067-6275-101 in 1 CARTON09/12/2011
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0067-6275-202 in 1 CARTON09/12/2011
    310 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4NDC:0067-6275-505 in 1 CARTON09/12/2011
    410 in 1 BLISTER PACK; Type 0: Not a Combination Product
    5NDC:0067-6275-726 in 1 CARTON09/12/2011
    512 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:0067-6275-8210 in 1 CARTON09/12/201111/23/2019
    612 in 1 BLISTER PACK; Type 0: Not a Combination Product
    7NDC:0067-6275-01120 in 1 CARTON; Type 0: Not a Combination Product08/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33209/12/2011
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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