Label: PHAZYME- simethicone capsule, gelatin coated

  • NDC Code(s): 0132-0208-12, 0132-0208-48
  • Packager: C.B. Fleet Company, 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 December 17, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each fast gel)

    Simethicone 180mg

  • 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 59°-86°F (15°-30°C).

  • Inactive Ingredients

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

  • Questions?

    Call toll-free 1-855-727-4277

    TAMPER EVIDENT PACKAGE

    Do not use if blister or printed foil is broken or torn, or if “PZ180” is missing from Fast Gel.

  • Principal Display Panel

    PHAZYME® ULTRA STRENGTH

    ANTI-GAS SIMETHICONE 180 MG

    12 fast gels

    PHAZYME® ULTRA STRENGTH ANTI-GAS SIMETHICONE 180 MG 12 fast gels

  • INGREDIENTS AND APPEARANCE
    PHAZYME 
    simethicone capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0208
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code PZ;180
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0208-121 in 1 BOX02/01/2012
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0132-0208-481 in 1 BOX02/01/2012
    248 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart33202/01/2012
    Labeler - C.B. Fleet Company, Inc. (003119054)
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