Label: PHAZYME- simethicone capsule, gelatin coated

  • 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 September 1, 2017

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  • Active Ingredient

    (in each softgel)

    Simethicone 250mg

  • Purpose

    Anti-gas

  • Use

    relieves bloating, pressure or fullness commonly referred to as gas

  • Warnings

    Stop use and ask a doctor if

    Stop use and ask a doctor if condition persists

    Keep out of reach of children.

  • Directions

    • swallow one or two softgels after a meal
    • do not exceed two softgels per 24 hours except under the advice and supervision of a physician
  • Other Information

    • store at room temperature 59º - 86ºF (15º - 30ºC)
  • Inactive Ingredients

    Red No. 33, FD&C Blue No. 1, Purified Water, Gelatin, Glycerin, Titanium Dioxide

  • Questions?

    Call toll-free 1-855-727-4277

  • PRINCIPAL DISPLAY PANEL

    Phazyme 250mg 36 ct CartonPhazyme 250mg 36 ct Carton

  • INGREDIENTS AND APPEARANCE
    PHAZYME 
    simethicone capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0215
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code PZ;250
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0215-371 in 1 BOX04/01/2014
    136 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33204/01/2014
    Labeler - C.B. Fleet Company, Inc. (003119054)
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