PHAZYME- simethicone capsule, gelatin coated
Preferred Pharmaceuticals, 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 Anti-Gas

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
36 SOFTGELS (180mg) - 68788-0758-3
Phazyme

PHAZYME
simethicone capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68788-0758(NDC:63029-550)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE 410 (UNII: TYU5GP6XGE) (DIMETHICONE 410 - UNII:TYU5GP6XGE)	DIMETHICONE 410	180 mg

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68788-0758-3	1 in 1 BOX	02/03/2014	02/14/2019
1		36 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	02/03/2014	02/14/2019

Labeler - Preferred Pharmaceuticals, Inc. (791119022)

Registrant - Preferred Pharmaceuticals, Inc. (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals, Inc.		791119022	RELABEL(68788-0758)

Revised: 2/2019

Document Id: 5f96279d-737c-4421-8b8d-2931a537e947

Set id: 990ebac2-e65d-409f-b979-36f52b13e26e

Version: 4

Effective Time: 20190214

Preferred Pharmaceuticals, Inc.