PHAZYME ULTIMATE- simethicone capsule, liquid filled

PHAZYME ULTIMATE by

Drug Labeling and Warnings

PHAZYME ULTIMATE 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 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

• Swallow (1) Fast Gel as symptoms occur
  
• Do not exceed (1) Fast Gel per 24 hours except under the advice and supervision of a physician

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

INGREDIENTS AND APPEARANCE

PHAZYME ULTIMATE 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0132-0217
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	500 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color	blue	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	PZ500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0132-0217-10	1 in 1 BOX	02/15/2021
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 0132-0217-20	2 in 1 BOX	02/15/2021
2		10 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	02/15/2021

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