Label: PHAZYME- simethicone capsule, gelatin coated

  • NDC Code(s): 0132-0211-12, 0132-0211-24, 0132-0211-36
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each fast gel)

    Simethicone 250 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 fast gels as symptoms occur.
    • Do not exceed two fast gels per 24 hours except under the advice and supervision of a physician.
  • Other information

    Store at room temperature 59º-86ºF (15º-30ºC). 

  • Inactive Ingredients

    DC Red #33, FD&C Blue #1, gelatin, glycerin, purified water

  • Questions?

    Call toll-free 1-855-727-4277

  • Principal Display Panel

    PHAZYME®

    ANTI-GAS SIMETHICONE 250 mg

    MAXIMUM STRENGTH

    12 fast gels

    Principal Display Panel PHAZYME® ANTI-GAS SIMETHICONE 250 mg MAXIMUM STRENGTH 12 fast gels

  • INGREDIENTS AND APPEARANCE
    PHAZYME 
    simethicone capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0211
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code PZ;250
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0211-121 in 1 BOX04/01/2014
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0132-0211-242 in 1 BOX04/01/2014
    212 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0132-0211-363 in 1 BOX04/01/2014
    312 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00204/01/2014
    Labeler - C.B. Fleet Company, Inc. (003119054)
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