Label: TOPCARE EXTRA STRENGTH GAS RELIEF CHERRY CREME- simethicone tablet, chewable

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

Drug Label Information

Updated November 20, 2023

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  • Active ingredient (in each tablet)

    Simethicone 125 mg

  • Purpose

    Anti-gas

  • Uses

    Foe the relief of

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

    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 hour except under the advice and supervision of a physician
  • Other information

    ▪
    each tablet contains: calcium 45 mg
    ▪
    store at room temperature
    ▪
    protect from excessive heat and moisture
  • Inactive ingredients

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

  • Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    NDC 36800-488-48

    COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT*

    EXTRA STRENGTH

    Gas Relief

    ANTIGAS/SIMETHICONE 125 mg

     
    FOR FAST RELIEF OF
    •
    Bloating
    •
    Pressure
    •
    Discomfort of Gas

    CHERRY CREME FLAVOR

    Naturally and Artificially Flavored

    48 CHEWABLE TABLETS

    DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

    DISTRIBUTED BY: TOPCO ASSOCIATES LLC,

    ELK GROVE VILLAGE, IL 60007

    © TOPCO RARA1217

    QUESTIONS? 1-888-423-0139

    topcare@topco.com, www.topcarebrand.com

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

    TopCare Extra Strength Simethicone 48 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    TOPCARE EXTRA STRENGTH GAS RELIEF  CHERRY CREME
    simethicone tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-488
    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:36800-488-4848 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00203/07/2019
    Labeler - TOPCO ASSOCIATES LLC (006935977)
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