PHAZYME- dimethicone 410 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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Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

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 59° - 86° F (15°- 30°C)

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

Phazyme®

ANTI-GAS/ SIMETHICONE 180mg

ULTRA STRENGTH

STRONGEST DOSE AVAILABLE!

RELIEVES GAS FAST

•: Pressure
•: Bloating
•: Discomfort

Goes to Work in Minutes

60 SOFTGELS (180mg)

Easy to Swallow

•: Has the highest dose of simethicone available
•: Goes to work in minutes
•: Contains a powerful ingredient, simethicone, the anti-gas medicine recommended most by physicians & pharmacists for relief of gas

Serious medicine for serious gas!®

TAMPER EVIDENT PACKAGE - Do not use if seal under cap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing or if "PZ 180" is missing from the softgel.

Distributed by:

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

PHAZYME® and other elements are registered trademarks of the GlaxoSmithKline group of companies.

28510XD

PHAZYME
simethicone capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68788-9070(NDC:0135-0429)
Route of Administration	ORAL	DEA Schedule

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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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

#	Item Code	Package Description
Packaging
1	NDC:68788-9070-3	1 in 1 CARTON
1		36 in 1 BOTTLE; 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	05/04/2011	09/30/2015

Labeler - Preferred Pharmaceuticals, Inc. (791119022)

Registrant - Preferred Pharmaceuticals, Inc. (791119022)

Name	Address	ID/FEI	Business Operations
Establishment
Preferred Pharmaceuticals, Inc.		791119022	RELABEL(68788-9070)

Revised: 10/2014

Document Id: e731a479-1e8c-4e9d-afd3-614c74d74162

Set id: bbc31ab7-e0ff-4b38-8431-82401402a89f

Version: 2

Effective Time: 20141028

Preferred Pharmaceuticals, Inc.