Label: GAS RELIEF ULTRA STRENGTH- dimethicone capsule 

  • 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 05/14

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

  • Active ingredient (in each softgel)

    Simethicone 180 mg

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  • Purpose

    Antiflatulent (Antigas)

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  • Uses

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

    Stop using this product and ask a doctor if

    condition persists.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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  • Directions

    • swallow one or two softgels as needed after a meal
    • do not exceed two softgels per day except under the advice and supervision of a physician
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  • Other information

    • store at 15º-30ºC (59º-86ºF)
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  • Inactive ingredients

    edible ink, FD&C yellow #6, gelatin, glycerin, purified water

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  • Questions or comments?

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

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  • Principal Display Panel

    COMPARE TO PHAZYME® ULTRA STRENGTH ACTIVE INGREDIENT*

    Gas Relief

    Ultra Strength Antigas

    Relieves bloating, pressure, fullness & gas

    Simethicone 180 mg

    RELIEVES GAS SYMPTOMS

    SOFTGELS 180 mg EACH

    *This product is not manufactured or distributed by C.B. Fleet Company, Inc., distributor of Phazyme®. 

    Another Quality Product Distributed by McKesson

    One Post Street, San Francisco, CA 94104

    Please visit us at www.sunmarkbrand.com

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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  • Product Label

    Simethicone 180 mg

    Sunmark Gas Relief Softgel

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  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  ULTRA STRENGTH
    simethicone capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-489
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIMETHICONE (DIMETHICONE) DIMETHICONE 180 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C YELLOW NO. 6  
    GELATIN  
    GLYCERIN  
    WATER  
    Product Characteristics
    Color ORANGE Score no score
    Shape OVAL Size 12mm
    Flavor Imprint Code S180
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-489-12 1 in 1 CARTON
    1 60 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part332 07/09/2010
    Labeler - McKesson (Sunmark) (177667227)
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