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Gas Relief (TOP CARE (Topco Associates LLC))

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 2 BLISTER PACK in 1 CARTON (36800-550-30) > 15 CAPSULE, LIQUID FILLED in 1 BLISTER PACK Label Information
CAPSULE, LIQUID FILLED 5 BLISTER PACK in 1 CARTON (36800-550-50) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK Label Information

Complete Gas Relief Information

  • Active ingredient (in each softgel)

    Simethicone 125 mg


  • Purpose

    Antiflatulent (Antigas)


  • Use

    • relieves bloating, pressure, or fullness commonly referred to as gas 

  • Warnings

    Stop use and ask a doctor if

    condition persists.

    If pregnant or breast-feeding,

    ask a health care professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.


  • Directions


    • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
    • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)
    • protect from heat and moisture

  • Inactive ingredients

    D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, sorbitol special, titanium dioxide


  • Questions or comments?

    Call toll free: 1-888-423-0139


  • Principal Display Panel

    EXTRA STRENGTH

    Gas Relief

    Simethicone, 125 mg

    • Relieves bloating, pressure, fullness and gas

    COMPARE TO EXTRA STRENGTH GAS-X® active ingredient*

    SOFTGELS

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK.

    DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

    *This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Extra Strength Gas-X®.

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL  60007

    topcare@topco.com


  • Product Label

    Simethicone 125 mg

    Top Care Gas Relief Softgel


  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-550
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 125 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color GREEN Score no score
    Shape OVAL Size 9mm
    Flavor Imprint Code PO
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-550-30 2 in 1 CARTON
    1 15 in 1 BLISTER PACK
    2 NDC:36800-550-50 5 in 1 CARTON
    2 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 05/31/2013
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
    Registrant - P and L Development of New York Corporation (800014821)