GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PUBLIX SUPER MARKETS INC]

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GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [PUBLIX SUPER MARKETS INC]
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NDC 56062-657-72
Set ID aafa7da9-53d7-478a-805e-e68cdf54ed2b
Category HUMAN OTC DRUG LABEL
Packager Publix Super Markets Inc
Generic Name
Product Class
Product Number
Application Number PART332
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  • Active ingredient (in each softgel)

    Simethicone 180 mg

  • Purpose

    Anti-gas

  • Use

    •
    relieves bloating, pressure or fullness commonly referred to as gas
  • Warnings

    Stop use and ask a doctor if

    condition persists

    Keep out of reach of children.

  • Directions

    •
    swallow one or two softgels as needed after a meal
    •
    do not exceed two softgels per day except under the advice and supervision of a physician
  • Other information

    •
    each softgel contains: potassium 5 mg
    •
    store at 68°-77°F (20°-25°C)
  • Inactive ingredients

    FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin

  • Principal Display Panel

    ULTRA STRENGTH

    gas relief

    SIMETHICONE 180mg

    ANTI-GAS

    Fast Relief of:

    pressure

    bloating

    gas discomfort

    Compare to the Active Ingredient in Phazyme® Ultra Strength

    60 SOFTGELS

    Publix Gas Relief image 1
    Publix Gas Relief image 2
  • INGREDIENTS AND APPEARANCE
    GAS RELIEF 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-657
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code L657
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56062-657-721 in 1 CARTON11/18/2003
    160 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33211/18/2003
    Labeler - Publix Super Markets Inc (006922009)
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