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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Drug Facts

Active Ingredient

(in each softgel)

Simethicone 250mg

Purpose

Anti-gas

Use

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

Stop use and ask a doctor if condition persists

Keep out of reach of children.

Directions

Other Information

Inactive Ingredients

Red No. 33, FD&C Blue No. 1, Purified Water, Gelatin, Glycerin, Titanium Dioxice

Questions?

Call toll-free 1-855-727-4277

Phazyme 250 mg 24 ct CartonPhazyme 250 mg 24 ct Carton

PHAZYME 
simethicone capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0214
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)  
WATER (UNII: 059QF0KO0R)  
GELATIN (UNII: 2G86QN327L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorpurpleScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code PZ;250
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0132-0214-241 in 1 BOX04/01/2014
124 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: 9/2017
Document Id: 092e34ee-561f-4ffa-bef7-4cad045b3f33
Set id: 470d2ea9-a869-47c5-9073-f970f58a0801
Version: 2
Effective Time: 20170901
 
C.B. Fleet Company, Inc.