Label: KROGER 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 August 23, 2023

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  • Active ingredient (in each tablet)

    Simethicone 125 mg

  • Purpose

    Anti-gas

  • Uses

    for the 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 swallow tablets whole.
    ▪
    do not exceed 4 tablets in a 24 hours except under the advice and supervision of a physician.
  • Other information

    ▪
    each tablets contains: calcium 45 mg
    ▪
    store at room temperature
    ▪
    protect from excessive heat and moisture

    TAMPER EVIDENT: DO NOT USE IF ANY INDVIDUAL BLISTER IS BROKEN OR OPEN

  • Inactive ingredients

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

  • Principal Display Panel

    NDC 30142-481-48

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

    Extra Strength

    Gas Relief

    Simethicone//Anti-gas

    For Fast Relief of Pressure,

    Bloating & Gas Distress

    Cherry Creme Flavor

    Naturally and Artificially Flavored

    48 Chewable Tablets

    Distributed by:

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

    IMPORTANT: Keep this carton for future reference on full labeling.
    Kroger Extra Strength Gas Relief Simethicone
  • INGREDIENTS AND APPEARANCE
    KROGER EXTRA STRENGTH  GAS RELIEF
    simethicone antigas tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-481
    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:30142-481-4812 in 1 CARTON03/30/2020
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33203/30/2020
    Labeler - KROGER COMPANY (006999528)
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