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

  • Label RSS
  • NDC Code(s): 41520-242-30, 41520-242-36
  • Packager: Care One (American Sales Company)
  • 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 11/13

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

  • Active ingredient (in each softgel)

    Simethicone 125 mg

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  • Purpose

    Antigas

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  • Uses

    • for the relief of pressure, bloating, and fullness commonly referred to as gas
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  • Warnings

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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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 unless directed by a doctor
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  • Other information

    • store at controlled room temperature 20-25°C (68-77°F)
    • protect from light, 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, medium-chain triglycerides*, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide

    *may contain this ingredient

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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 the active ingredient in Gas-X®†

    EXTRA STRENGTH

    GAS RELIEF

    SIMETHICONE 125 mg

    Antigas

    Relieves

    • Pressure
    • Bloating
    • Fullness
    • Gas

    SOFTGEL

    †This product is not manufactured or distributed by Novartis, owner of the registered trademark Gas-X®.

    Distributed by:

    Foodhold U.S.A., LLC

    Landover, MD 20785

    1-877-846-9949

    © 2013 Ahold Licensing, Sarl

    Quality guaranteed or your money back

    TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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  • Product Label

    CareOne

    Simethicone 125 mg softgels

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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:41520-242
    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  
    MEDIUM-CHAIN TRIGLYCERIDES  
    PEPPERMINT OIL  
    WATER  
    SORBITAN  
    SORBITOL  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color GREEN Score no score
    Shape OVAL Size 9mm
    Flavor Imprint Code PO;S1;SCU
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41520-242-36 2 in 1 CARTON
    1 18 in 1 BLISTER PACK
    2 NDC:41520-242-30 2 in 1 CARTON
    2 15 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part347 11/15/2013
    Labeler - Care One (American Sales Company) (809183973)
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