Label: EXTRA STRENGTH GAS RELIEF CHERRY CREME FLAVORED- simethicone 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 January 21, 2021

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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 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 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

    QC® QUALITY CHOICE

    NDC 63868-854-18

    *Compare to the Active Ingredient in Gas-X® Extra Strength

    Gas Relief

    Extra Strength, Simethicone 125 mg

    Relieves:

    Discomfort

    Pressure

    Bloating

    Cherry Creme Flavored Chews

    Naturally and Artificially Flavored

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

    100% QC SATISFACTION GURANTEED

    Distributed by C.D.M.A., Inc.© 43157 W 9 Mile Rd Novi, MI 48375

    www.qualitychoice.com

    Questions: 248-449-9300

    EXTRA STRENGTH SIMETHICONE 125 MG CHERRY CREME FLAVORED
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH GAS RELIEF  CHERRY CREME FLAVORED
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-854
    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:63868-854-182 in 1 CARTON03/20/2019
    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 finalpart33203/20/2019
    Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)
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