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Gas Relief (QUALITY CHOICE (Chain Drug Marketing Association))

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 2 BLISTER PACK in 1 CARTON (63868-125-30) > 15 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 and titanium dioxide


  • Questions or comments?

    Call 1-248-449-9300 Monday-Friday 9AM-5PM EST 


  • Principal Display Panel

    Compare to the active ingredient in EXTRA STRENGTH GAS-X®*

    Extra Strength

    Gas Relief

    Antiflatulent

    Simethicone 125 mg

    For Relief of:

    Bloating | Pressure | Fullness | Gas

    Softgels

    EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK.

    DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Distributed by C.D.M.A., Inc.

    43157 W. Nine Mile

    Novi, MI  48376-0995

    www.qualitychoice.com

    Questions: 248-449-9300

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


  • Product Label

    Simethicone 125 mg

    Quality Choice Extra Strength Gas Relief Simethicone 125 mg


  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-125
    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)  
    SORBITAN (UNII: 6O92ICV9RU)  
    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:63868-125-30 2 in 1 CARTON
    1 15 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part332 07/14/2010
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
    Registrant - P and L Development of New York Corporation (800014821)