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

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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

  • 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

    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.

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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?

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

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  • Principal Display Panel

    Compare to Extra Strength Gas-X® active ingredient*

    Gas Relief

    Extra Strength

    • Discomfort
    • Pressure
    • Bloating

    Simethicone 125 mg

    Relieves gas symptoms

    *This product is not manufactured or distributed by Novartis consumer health, Inc., owner of the registered trademark Extra strength Gas-X®

    Another quality product distributed by McKesson

    one post street, San Francisco, CA 94104

    Money back gurantee

    Please visit us at www.sunmarkbrand.com

    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.


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  • Product Label

     Sunmark gas relief extra strength

    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 LABEL Item Code (Source) NDC:49348-946
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 125 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    GELATIN  
    GLYCERIN  
    PEPPERMINT OIL  
    WATER  
    SORBITOL  
    TITANIUM DIOXIDE  
    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:49348-946-44 2 in 1 BOX
    1 15 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 04/12/2011
    Labeler - McKesson (Sunmark) (177667227)
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