Label: GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled

  • NDC Code(s): 49035-550-14, 49035-550-20, 49035-550-60, 49035-550-72
  • Packager: EQUATE (Wal-Mart Stores, Inc.)
  • 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 3, 2013

If you are a consumer or patient please visit this version.

  • DRUG FACTS
  • Active Ingredient (in each softgel)

    Simethicone 125 mg

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  • Purpose

    Antiflatulent (Antigas)

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  • Use

    • relieves bloating, pressure, or fullness commonly referred to as gas.
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  • Warnings
  • Stop use and ask a doctor if

    condition persists

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  • If pregnant or breast-feeding,

     ask a health care professional before use

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  • Keep out of reach of children.

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

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  • 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
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  • 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.

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  • Questions or comments?

    1-888-287-1915

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  • Principal Display Panel

    Compare to Extra Strength Gas-X® active ingredient*

    Extra Strength

    Gas Relief

    Anti-Gas/ Simethicone

    Relieves:

    • Pressure
    • Bloating
    • Discomfort

    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

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

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  • Product Label

    Equate

    Simethicone 125 mg

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  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-550
    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:49035-550-72 4 in 1 CARTON 07/06/2010 12/31/2020
    1 18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2 NDC:49035-550-60 4 in 1 CARTON 07/06/2010 12/31/2020
    2 15 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3 NDC:49035-550-20 2 in 1 CARTON 07/06/2010 12/31/2020
    3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    4 NDC:49035-550-14 2 in 1 PACKAGE 07/06/2010 12/31/2020
    4 72 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part332 07/06/2010 12/31/2020
    Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)
    Registrant - P & L Development, LLC (800014821)
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