Label: CVS HEALTH ULTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Simethicone 180 mg

  • Purpose

    Antigas

  • Uses

    for the relief of
    ■ pressure and bloating commonly referred to as gas

  • Warnings

    Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    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 2 softgels in 24 hours except under the advice and
    supervision of a physician

  • Other information

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

  • Inactive ingredients

    FD&C yellow #6, gelatin, glycerin, peppermint oil, povidone, purified
    water, sorbitol solution, titanium dioxide

  • QUESTIONS

    Questions or comments? 1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    CVS Health Ultra Strength Gas Relief

    Compare to the active
    ingredient in Gas-X®
    Ultra Strength Softgels*
    Simethicone 180mg

    Anti-gas

    Fast Relief of:

    Bloating

    Pressure

    Fullness

    Gas

    Easy to swallow softgels

    50 Softgels

    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.

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

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2019 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS
    Made in India
    V-31141

    image description

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH ULTRA STRENGTH GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-677
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POVIDONE K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colororange (opaque) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code 161
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-677-501 in 1 CARTON06/05/2019
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00206/05/2019
    Labeler - CVS Pharmacy (062312574)
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