PHAZYME- simethicone capsule, gelatin coated 
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 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

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

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)

Revised: 12/2020
Document Id: fa4012b5-0ff1-4521-b066-0cac49f1486f
Set id: 3bb5cc1f-554b-4a4d-b9e9-665e34924b4b
Version: 9
Effective Time: 20201217
 
C.B. Fleet Company, Inc.