Label: CVS PHARMACY EXTRA STRENGTH GAS RELIEF- simethicone antigas tablet, chewable

  • 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 September 12, 2023

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  • Active Ingredient (in each tablet)

    Simethicone 125 mg

  • PURPOSE

    Anti-gas

  • 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: chew 1 to 2 tablets completely as needed after meals and at bedtime, Do not swallow tablets whole.
    ▪
    do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician
  • Other Information

    ▪
    each tablet contains: calcium 45 mg
    ▪
    store at room temperature
    ▪
    protect from moisture
  • Inactive Ingredients

    D&C yellow # 10, dextrose, flavors, magnesium stearate, microcrystalline cellulose, silicon dioxide, sucralose, tribasic calcium phosphate

  • Questions or comments

    1-866-467-2748

  • Principal Display Panel

    *Compare to the active ingredient in Gas-X Extra Strength
    NDC 51316-011-18
    Extra strength
    Gas Relief
    Simethicone 125 mg/Anti-Gas
    Fast Relief of Pressure, Bloating & Discomfort


    Peppermint Flavor

    Naturally and Artificially Flavored

    18 Chewable Tablets

    *This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Gas-X Extra Strength.

    IMPORTANT: Keep this carton for future reference on full labeling.

    CVS Extra Strength Gas Relief 18 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  EXTRA STRENGTH GAS RELIEF
    simethicone antigas tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeROUNDSize14mm
    FlavorPEPPERMINTImprint Code RP110
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-011-182 in 1 CARTON08/05/2021
    19 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33208/05/2021
    Labeler - CVS (062312574)
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