Label: GAS RELIEF- simethicone capsule, liquid filled

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

Drug Label Information

Updated January 22, 2024

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  • Active ingredient (in each softgel)

    Simethicone 180 mg

  • Purpose

    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 professional before use.

    Keep out of reach of children.

  • Directions

    • swallow one or two softgels as symptoms occur
    • do not exceed two softgels per 24 hours except under the advice and supervision of a physician
  • Other information

    • store between 15-30ºC (59-86ºF)
    • protect from heat and moisture
  • Inactive ingredients

    FD&C yellow #6, gelatin, glycerin, water

  • Questions or comments?

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

  • Principal Display Panel

    Compare to the active ingredient in Phazyme® Ultra Strength*

    ULTRA STRENGTH

    Gas Relief

    SIMETHICONE, 180 mg

    Anti-gas

    Relief of:

    • Gas discomfort
    • Pressure
    • Bloating

    LIQUID-FILLED SOFTGELS

    *This product is not manufactured or distributed by Prestige Consumer Healthcare, Inc., distributor of Phazyme® Ultra Strength.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

  • Package Label

    Anti-gas

    CVS Health Ultra Strength Gas Relief Simethicone, 180 mg

  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-152(NDC:51013-115)
    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)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colororange (clear) Scoreno score
    ShapeCAPSULE (oval) Size10mm
    FlavorImprint Code PC3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-152-601 in 1 BOX12/31/2023
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:51316-152-2020 in 1 CARTON12/31/2023
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00212/31/2023
    Labeler - CVS PHARMACY, INC (062312574)
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