Label: PHAZYME- simethicone capsule, gelatin coated

  • NDC Code(s): 0132-0208-12, 0132-0208-48, 0132-0208-84
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 27, 2024

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  • PHAZYME- SIMETHICONE CAPSULE, GELATIN COATED 

    Phazyme Ultra Strength 180 mg 0132-0208

    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

  • Principal Display Panel

    PHAZYME® ULTRA STRENGTH

    ANTI-GAS SIMETHICONE 180 MG

    48 fast gels

    Principal Display Panel PHAZYME® ULTRA STRENGTH ANTI-GAS SIMETHICONE 180 MG 48 fast gels

  • Principal Display Panel

    PHAZYME® ULTRA STRENGTH

    ANTI-GAS SIMETHICONE 180 MG

    Principal Display Panel PHAZYME® ULTRA STRENGTH ANTI-GAS SIMETHICONE 180 MG

  • 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 BOX02/01/201212/31/2024
    248 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:0132-0208-841 in 1 BOX02/01/2012
    348 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00202/01/2012
    Labeler - C.B. Fleet Company, Inc. (003119054)
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