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 41520-550-30, 41520-550-36
Set ID eeae6bcb-9d38-4d0b-ad00-1f019225a2c6
Category HUMAN OTC DRUG LABEL
Packager Care One (American Sales Company)
Generic Name
Product Class
Product Number
Application Number PART332
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  • Drug Facts

  • Active Ingredient (in each softgel)

    Simethicone 125 mg

  • Purpose

    Antiflatulent (Antigas)

  • Use

    relieves bloating, pressure, or fullness commonly referred to as gas.

  • 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.

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

  • Questions or comments?

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

  • Principal Display Panel

    Compare to the active ingredient in Extra Strength Gas-X®*

    Extra Strength

    GAS RELIEF

    Simethicone 125 mg

    relieves:

    • pressure
    • bloating 
    • fullness 
    • gas

    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

    Distributed by: American Sales Company

    4201 walden ave, Lancaster, NY 14086

    www.care1.com

  • Product Label

    CareOne

    Simethicone 125 mg

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-550
    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)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code PO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-550-362 in 1 CARTON10/27/201001/01/2022
    118 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:41520-550-302 in 1 CARTON10/27/201001/01/2022
    215 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33210/27/201001/01/2022
    Labeler - Care One (American Sales Company) (809183973)
    Registrant - P & L Development, LLC (800014821)
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