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Gas Relief (Freds Inc)

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CAPSULE, LIQUID FILLED 2 BLISTER PACK in 1 CARTON (55315-550-03) > 15 CAPSULE, LIQUID FILLED in 1 BLISTER PACK Label Information

Complete Gas Relief Information

  • Active Ingredient (in each softgel)

    Simethicone 125mg


  • 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 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 toll free: 1-877-753-3935 Monday- Friday 9AM- 5PM EST


  • Principal Display Panel

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

    Gas Relief

    Extra Strength

    Simethicone, 125mg

    Relief of:

    bloating, pressure, fullness, gas

    EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK.

    DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

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

    Distributed by: Fred's Inc.

    4300 New getwell rd, memphis, TN 38118

    www.fredsinc.com


  • Product Label

    Freds Inc Gas relief

    Gas relief Simethicone 125 mg


  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-550
    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:55315-550-03 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 08/29/2012
    Labeler - Freds Inc (005866116)