Label: PUBLIX EXTRA STRENGTH- simethicone capsule, liquid filled

  • NDC Code(s): 41415-113-30
  • Packager: PUBLIX SUPER MARKETS, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 2023

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  • Active ingredient (in each softgel)

    Simethicone 125 mg

  • Purpose

    Antigas

  • Uses

    for 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 room temperature
    ▪
    protect from light, heat and moisture.
  • Inactive ingredients

    D&C yellow No. 10, FD&C blue No. 1, FD&C red No. 40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide.

    Questions or comments?

    1-866-467-2748

  • Principal Display Panel

    NDC 41415-113-30

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

    Extra Strength

    Gas Relief

    SIMETHICONE 125 MG/ANTI-GAS

    Relieves:

    •
    Discomfort
    •
    Pressure
    •
    Bloating

    30 SOFTGELS

    IMPORTANT: Keep this carton for future reference on full labeling.

    DISTRIBUTED BY: PUBLIX SUPER MARKETS, INC.,

    3300 PUBLIX CORPORATE PARKWAY

    LAKELAND, FL 33811

    1-888-267-3037 publix.com

    PUBLIX GUARANTEE:

    COMPLETE SATISFACTION OR YOUR MONEY BACK

    *This product is not manufactured or distributed by GSK Consumer Healthcare, Inc., the distributor of Gas-X® Extra Strength.

    DO NOT USE IF ANY INDIVIDUAL BLISTERS UNIT IS BROKEN OR OPEN.

    Extra Strength Gas Relief 30 Softgels
  • INGREDIENTS AND APPEARANCE
    PUBLIX  EXTRA STRENGTH
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41415-113
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code RP113
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41415-113-302 in 1 CARTON05/14/2019
    115 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00205/14/2019
    Labeler - PUBLIX SUPER MARKETS, INC (006922009)
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