Label: PREMIER VALUE EXTRA STRENGTH- simethicone tablet, chewable

  • NDC Code(s): 68016-811-18
  • Packager: PHARMACY VALUE ALLIANCE, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 3, 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 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

    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

    Premier Value®

    NDC 68016-811-18

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

    Extra Strength

    Gas Relief

    Antigas/Simethicone 125 mg

    Relieves:

    •
    Pressure
    •
    Bloating
    •
    Discomfort

    Cherry Creme Flavor

    Naturally and Artificially Flavored

    18 CHEWABLE TABLETS

    K PAREVE

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

    Distributed by:

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

    IMPORTANT: Keep this carton for future reference on full labeling.
    Premier Value Extra Strength Simethicone
  • INGREDIENTS AND APPEARANCE
    PREMIER VALUE  EXTRA STRENGTH
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-811
    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 (CREME) Imprint Code RP110
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-811-182 in 1 CARTON05/15/2019
    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 DrugM00205/15/2019
    Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)
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