GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]

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GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]
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NDC 41520-242-30, 41520-242-36
Set ID a761d384-0b5a-4d93-93ae-43b9fcaa6139
Category HUMAN OTC DRUG LABEL
Packager Care One (American Sales Company)
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active ingredient (in each softgel)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Uses

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

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

  • 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
  • Other information

    • store at controlled room temperature 20-25°C (68-77°F)
    • protect from light, heat, and moisture
  • 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

  • Questions or comments?

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

  • 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.

  • Product Label

    CareOne

    Simethicone 125 mg softgels

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-242
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code PO;S1;SCU
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-242-302 in 1 CARTON11/15/201301/01/2022
    115 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41520-242-362 in 1 CARTON11/15/201301/01/2022
    218 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34711/15/201301/01/2022
    Labeler - Care One (American Sales Company) (809183973)
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