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

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

Drug Label Information

Updated November 14, 2023

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  • Active Ingredient (in each tablet)

    Simethicone 125 mg

  • PURPOSE

    Anti-gas

  • USE(S)

    relieves:

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

  • Keep out of reach of children

    In case of overdose, get medical help or contact a poison control center immediately.

  • Directions

    ▪
    adults and Childrens 12 years and older: chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
    ▪
    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 red # 30 aluminum lake, D&C yellow # 10 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose

  • Principal Display Panel

    *Compare to the active ingredient in Gas-X Extra Strength
    NDC 21130-441-48
    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.

    Extra Strength Gas Relief 18 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH GAS RELIEF 
    simethicone antigas tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-441
    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:21130-441-182 in 1 CARTON10/01/2020
    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 DrugM00210/01/2020
    Labeler - SAFEWAY (009137209)
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