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

  • NDC Code(s): 0067-6283-01, 0067-6283-02
  • 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 250 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 and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
    •
    do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician
  • Other information

    •
    store at a controlled room temperature 20-25°C (68-77°F)
    •
    protect from light heat and moisture
  • Inactive ingredients

    D&C red no. 33, FD&C blue no. 1, gelatin, glycerin, lecithin, purified water, titanium dioxide

  • Questions or comments?

    Call 1-800-328-5204

  • Principal Display Panel

    NEW

    #1 DOCTOR RECOMMENDED BRAND

    NDC 0067-6283-02

    Gas-X

    SIMETHICONE 250 mg/ ANTIGAS

    Goes to work in Minutes

    RELIEVES GAS FAST

    PRESSURE • BLOATING • DISCOMFORT

    MAXIMUM STRENGTH

    50 SoftGels

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

    TAMPER EVIDENT FEATURE:

    Do not use if blister is broken or damaged.

    Gas-X® Ultra 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.

    1-800-328-5204

    www.Gas-X.com

    Distributed by:

    GSK Consumer Healthcare

     
    Warren, NJ 07059

    ©2020 GSK group of companies or its licensor.

    Trademarks are owned by or licensed to the GSK group of companies.

    1000610

    1000610 GSX Maximum Strength 50 softgels
  • INGREDIENTS AND APPEARANCE
    GAS-X  MAXIMUM STRENGTH SOFTGELS
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6283
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPURPLE (opaque softgel with white print logo) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code GXM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-6283-013 in 1 CARTON03/10/2019
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0067-6283-025 in 1 CARTON03/31/2021
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33203/10/2019
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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