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

  • NDC Code(s): 0067-0119-01
  • 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 19, 2022

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  • 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)
  • Inactive ingredients

    alcohol, ammonium hydroxide, beeswax, carnauba wax, citric acid, corn syrup, dextrin, ethyl acetate, FD&C yellow 6, FD&C yellow 6 lake, flavor, gum arabic, isopropyl alcohol, maltodextrin, methylparaben, n-butyl alcohol, pharmaceutical ink, phosphoric acid, propylene glycol, propylparaben, purified water, shellac, sorbic acid, sorbitol, soy lecithin, sucrose, titanium dioxide, vegetable oil (coconut origin)

  • Questions or comments?

    1-855-328-5204

  • Additional Information

    DO NOT USE IF POUCH IS OPEN OR TORN.

    Dist. by: GSK CH, Warren, NJ 07059

    Trademarks owned or licensed by GSK.

    ©2021 GSK or licensor.

    Provides gas and heartburn relief

    1001388

  • Principal Display Panel

    NEW #1 DOCTOR RECOMMENDED BRAND

    NDC 0067-0119-01

    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

    2 Chewable Tablets

    1001388 – Front Pouch

    Gas X Total Relief_2 ct pouch
  • INGREDIENTS AND APPEARANCE
    GAS-X  TOTAL RELIEF MAXIMUM STRENGTH
    calcium carbonate, simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-0119
    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 YELLOW NO. 6 (UNII: H77VEI93A8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    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)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITOL (UNII: 506T60A25R)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SUCROSE (UNII: C151H8M554)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CORN OIL (UNII: 8470G57WFM)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeROUNDSize19mm
    FlavorBERRY (Mixed Berries) Imprint Code GT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-0119-012 in 1 POUCH; Type 0: Not a Combination Product02/03/2022
    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)
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