PHAZYME- simethicone capsule, gelatin coated

PHAZYME by

Drug Labeling and Warnings

PHAZYME by is a Otc medication manufactured, distributed, or labeled by Medtech Products 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 as needed after a meal
  
• do not exceed two softgels per day 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 1-866-255-5204 (English/Spanish) weekdays

PRINCIPAL DISPLAY PANEL

180mg ULTRA STRENGTH STRONGEST DOSE AVAILABLE!
PhaZyme ANTI-GAS/SIMETHICONE 180mg
100 SOFTGELS (180mg)
Easy to Swallow

INGREDIENTS AND APPEARANCE

PHAZYME 
simethicone capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-550
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE 410 (UNII: TYU5GP6XGE) (DIMETHICONE 410 - UNII:TYU5GP6XGE)	DIMETHICONE 410	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: 63029-550-02	1 in 1 BOX
1		12 in 1 BOTTLE, PLASTIC
2	NDC: 63029-550-36	1 in 1 BOX
2		36 in 1 BOTTLE, PLASTIC
3	NDC: 63029-550-60	1 in 1 BOX
3		60 in 1 BOTTLE, PLASTIC
4	NDC: 63029-550-01	1 in 1 BOX
4		100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part332	06/01/2012

Labeler - Medtech Products Inc. (122715688)