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 Maximum Strength 250 mg 0132 - 0211

Drug Facts

Active Ingredient (in each fast gel)

Simethicone 250 mg

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 59º-86ºF (15º-30ºC). 

Inactive Ingredients

DC Red #33, FD&C Blue #1, gelatin, glycerin, purified water

Questions?

Call toll-free 1-855-727-4277

Principal Display Panel

PHAZYME®

ANTI-GAS SIMETHICONE 250 mg

MAXIMUM STRENGTH

12 fast gels

Principal Display Panel

PHAZYME® 
ANTI-GAS SIMETHICONE 250 mg

MAXIMUM STRENGTH 

12 fast gels

PHAZYME 
simethicone capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0211
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE250 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorpurpleScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code PZ;250
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-0211-121 in 1 BOX04/01/2014
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0132-0211-242 in 1 BOX04/01/2014
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:0132-0211-363 in 1 BOX04/01/2014
312 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33204/01/2014
Labeler - C.B. Fleet Company, Inc. (003119054)

Revised: 5/2023
Document Id: f916cbab-92e9-46a7-aea1-df2dac2e05b2
Set id: ea04f5a5-cf56-4176-a234-5a73e01ff218
Version: 8
Effective Time: 20230509
 
C.B. Fleet Company, Inc.