Label: CAREONE GAS RELIEF- simethicone capsule, liquid filled

  • NDC Code(s): 41520-428-60
  • Packager: American Sales Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 November 6, 2017

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  • Active ingredient (in each softgel)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Use

    for the relief of

    •
    pressure, bloating and fullness, commonly referred to as gas
  • Warnings

    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 except under the advice and supervision of a physician
  • Other information

    •
    store at 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, peppermint oil, purified water, sorbitol sorbitan solution, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to the active ingredient in Gas-X®

    EXTRA STRENGTH

    GAS RELIEF

    Simethicone 125mg

    Anti-Gas

    Relieves Gas Fast

    Relieves:

    Discomfort

    Pressure

    Bloating

    Gluten Free

    Actual Size

    OUR PHARMACISTS RECOMMEND

    20 SOFTGELS

    428-of-gas relief.jpg
  • INGREDIENTS AND APPEARANCE
    CAREONE GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-428
    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)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code L428
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-428-6020 in 1 CARTON11/02/2017
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33211/02/2017
    Labeler - American Sales Company (809183973)
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