PHAZYME ULTIMATE- simethicone capsule, liquid filled 
C.B. Fleet Company, Inc.

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.

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Phazyme Ultimate 500 mg

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

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

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)

Revised: 12/2022
Document Id: 28126b40-bb23-4f17-920e-73d4d505b87a
Set id: 1ec2c8d4-e788-427b-9a66-134aa745580a
Version: 2
Effective Time: 20221208
 
C.B. Fleet Company, Inc.