Label: GAS RELIEF- simethicone capsule, liquid filled

  • NDC Code(s): 56062-657-72
  • Packager: Publix Super Markets Inc
  • 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 June 1, 2022

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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

    P

    ULTRA STRENGTH

    gas relief

    ANTI-GAS/SIMETHICONE 180 mg

    Relief of:

    • Pressure

    • Bloating

    • Gas Discomfort

    EASY TO SWALLOW

    Compare to the active ingredient of Phazyme® Ultra Strength

    60 SOFTGELS (180 mg)

    657-63-gas-relief
  • 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, UNSPECIFIED (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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