Label: EXTRA STRENGTH GAS RELIEF- simethicone tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2023

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  • Active ingredient (in each tablet)

    Simethicone 125 mg

  • Purpose

    Anti-gas

  • Uses for relief of

    ▪
    pressure, bloating and fullness commonly referred to as gas.
  • Warning

    Keep out of reach of children

  • Directions

    ▪
    adults: chew 1 to 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
    •
    store at room temperature
    •
    protect from excessive heat and moisture
  • Inactive ingredients

    D&C Red No. 30, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sucralose, tribasic calcium phosphate

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  • Principal Display Panel

     
    *Compare to the active ingredient in Gas-X® Extra Strength

    Extra Strength

    Gas Relief

    Simethicone /Antigas

    For Fast Relief of Pressure, Bloating & Discomfort

    Cherry Creme Flavor

    Natural and Artificially Flavored

    18 CHEWABLE TABLETS

    DO NOT USE IF ANY INDIVIDUAL BLISTER IS BROKEN OR OPEN

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

    Distributed by:

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

    Package Label for 18 Chewable Tablets

    Extra Strength Gas Relief Simethicone 18 Chewable Tablets

    Package Label for 48 Chewable Tablets

    Extra Strength Gas Relief Simethicone 48 Count
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH GAS RELIEF 
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-110
    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 RED NO. 30 (UNII: 2S42T2808B)  
    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
    ColorPINKScoreno score
    ShapeROUNDSize14mm
    FlavorCHERRY (Cherry Creme) Imprint Code RP110
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-110-183 in 1 CARTON10/02/2020
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:21130-110-4812 in 1 CARTON10/02/2020
    24 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00210/02/2020
    Labeler - SAFEWAY (009137209)
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