Label: GAS-X TOTAL RELIEF MAXIMUM STRENGTH- calcium carbonate, simethicone tablet, chewable

  • NDC Code(s): 0067-0118-02, 0067-0118-03
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL

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 January 14, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredients (per tablet)

    Calcium carbonate 750 mg

    Simethicone 250 mg

  • Purpose

    Antacid

    Antigas

  • Uses

    for the relief of

    pressure, bloating, and fullness commonly referred to as gas
    gas associated with heartburn, sour stomach, or acid indigestion
    acid indigestion
    heartburn
    sour stomach
    upset stomach associated with these symptoms
  • Warnings

    Ask a doctor or pharmacist before use if you are

    presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    do not exceed 2 tablets in 24 hours except under the advice and supervision of a doctor
    do not use the maximum dosage for more than 2 weeks, except under the advice and supervision of a doctor

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

  • Directions

    adults and children 12 years and older: chew 1 or 2 tablets as symptoms occur, or as directed by a doctor. Chew or crush tablets completely before swallowing.
    do not take for symptoms that persist for more than 2 weeks, unless advised by a doctor
  • Other information

    each tablet contains: elemental calcium 295 mg
    store in a cool, dry place at no higher than 25°C (77°F)
    contains FD&C Yellow 5 Lake (tartrazine) as a color additive
  • Inactive ingredients

    alcohol, ammonium hydroxide, beeswax, carnauba wax, citric acid, corn syrup, dextrin, ethyl acetate, FD&C red 40, FD&C red 40 lake, FD&C yellow 5 lake (tartrazine), FD&C yellow 6, FD&C yellow 6 lake, flavors, gum arabic, isopropyl alcohol, maltodextrin, methylparaben, n-butyl alcohol, pharmaceutical ink, phosphoric acid, propylene glycol, propylparaben, purified water, shellac,

    sodium benzoate, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, vegetable oil (coconut origin)

  • Questions or comments?

    1-855-328-5204

  • Additional Information

    TAMPER EVIDENT FEATURE: Do not use if printed inner safety seal under cap is broken or missing.

    Dist. by: GSK CH, Warren, NJ 07059

    Trademarks owned or licensed by GSK.

    ©2021 GSK or licensor.

    1001392

  • Principal Display Panel

    NEW #1 DOCTOR RECOMMENDED BRAND

    NDC 0067-0118-03

    Gas-X

    TOTAL RELIEF*

    Simethicone / Antigas

    Calcium Carbonate / Antacid

    *Provides gas and heartburn relief

    Fast Relief

    √ GAS √ HEARTBURN √ BLOATING √ DISCOMFORT

    MAXIMUM

    STRENGTH

    250 mg Simethicone

    Mixed Berries

    30 Chewable Tablets

    1001392 – Front Carton

    1001392_Gas X Total Relief_30 chewable tabs
  • INGREDIENTS AND APPEARANCE
    GAS-X  TOTAL RELIEF MAXIMUM STRENGTH
    calcium carbonate, simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-0118
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    AMMONIA (UNII: 5138Q19F1X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CORN SYRUP (UNII: 9G5L16BK6N)  
    DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
    ETHYL ACETATE (UNII: 76845O8NMZ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ACACIA (UNII: 5C5403N26O)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITOL (UNII: 506T60A25R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CORN OIL (UNII: 8470G57WFM)  
    Product Characteristics
    ColorPURPLE (Red) Scoreno score
    ShapeROUNDSize19mm
    FlavorBERRY (Mixed Berries, Strawberry) Imprint Code GT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-0118-031 in 1 CARTON02/03/2022
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0067-0118-021 in 1 CARTON02/03/2022
    265 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/03/2022
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)