Label: GAS-X EXTRA STRENGTH- simethicone tablet, chewable

  • NDC Code(s): 0067-0129-18, 0067-0129-27, 0067-0129-48
  • 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 February 6, 2019

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  • Active ingredient (in each tablet)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Uses

    for the relief of

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

    Keep out of reach of children.

  • Directions

    •
    adults: chew 1 or 2 tablets as needed after meals and at bedtime
    •
    do not exceed 4 tablets in 24 hours except under the advice and supervision of a physician
  • Other information

    •
    each tablet contains: calcium 45 mg
    •
    store at controlled room temperature 20-25°C (68-77°F)
    •
    protect from moisture
  • Inactive ingredients

    calcium phosphate tribasic, colloidal silicon dioxide, D&C Red 30 aluminum lake, D&C Yellow 10 aluminum lake, dextrose, flavors, maltodextrin, starch

  • Questions or comments?

    call 1-800-452-0051

  • Principal Display Panel

    NDC 0067-0129-48

    #1 DOCTOR RECOMMENDED BRAND

    Gas-X®

    SIMETHICONE 125 mg /ANTIGAS

    RELIEVES GAS FAST

    Pressure • Bloating • Discomfort

    EXTRA STRENGTH

    PEPPERMINT CREME

    48 Chewable Tablets

    Gas-X® Extra Strength Peppermint Creme chewable tablets have a pleasantly smooth, creamy mint flavor. Chewable tablets are also available in a great tasting Cherry Creme flavor.

    TAMPER EVIDENT FEATURE:

    Gas-X® tablets are sealed in blister packets. Use only if the individual seal is unbroken.

    Gas-X®Extra Strength Tablets 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.

    46176391

    46176391_Gas-X ES Peppermint Creme 0129_48 ct.JPG
  • INGREDIENTS AND APPEARANCE
    GAS-X  EXTRA STRENGTH
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-0129
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize14mm
    FlavorPEPPERMINT (Peppermint Creme) Imprint Code Gas;X;ES
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-0129-484 in 1 CARTON12/01/2012
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0067-0129-182 in 1 CARTON12/01/2012
    29 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0067-0129-273 in 1 CARTON12/01/2012
    39 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33201/01/2012
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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