Label: PHAZYME ULTIMATE- simethicone capsule, liquid filled

  • NDC Code(s): 0132-0217-10, 0132-0217-20
  • 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 8, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each fast gel)

    Simethicone 500mg

  • 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 (1) Fast Gel as symptoms occur
    • Do not exceed (1) Fast Gel 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 Blue #1, gelatin, glycerin, 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 “PZ500” is missing from Fast Gel.

  • Principal Display Panel

    PHAZYME® ULTIMATE

    ANTI-GAS SIMETHICONE 500 mg

    10 fast gels

    Principal Display Panel PHAZYME® ULTIMATE ANTI-GAS SIMETHICONE 500 mg 10 fast gels

  • INGREDIENTS AND APPEARANCE
    PHAZYME ULTIMATE 
    simethicone capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0217
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code PZ500
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0217-101 in 1 BOX02/15/2021
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0132-0217-202 in 1 BOX02/15/2021
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33202/15/2021
    Labeler - C.B. Fleet Company, Inc. (003119054)
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