PHAZYME- simethicone capsule, gelatin coated

PHAZYME by

Drug Labeling and Warnings

PHAZYME by is a Otc medication manufactured, distributed, or labeled by C.B. Fleet Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

(in each softgel)

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

• swallow one or two softgels after a meal
• do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information

• store at room temperature 59º - 86ºF (15º - 30ºC)

Inactive Ingredients

FD&C Yellow No. 6, Gelatin, Glycerin, White Edible Ink

Questions?

Call toll-free 1-855-727-4277

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PHAZYME 
simethicone capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0208
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	180 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	PZ;180
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0208-12	1 in 1 BOX	02/01/2012
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0132-0208-60	1 in 1 BOX	02/01/2012	08/31/2017
2		60 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 0132-0208-48	1 in 1 BOX	02/01/2012
3		48 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part332	02/01/2012

Labeler - C.B. Fleet Company, Inc. (003119054)