GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled

gas relief by

Drug Labeling and Warnings

gas relief by is a Otc medication manufactured, distributed, or labeled by EQUATE (Wal-Mart Stores, Inc.), P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antiflatulent (Antigas)

Use

• relieves bloating, pressure, or fullness commonly referred to as gas

Warnings

Stop using this product and ask a doctor if

condition persists.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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 controlled room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

edibile ink, FD&C yellow # 6, gelatin, glycerin and purified water

Questions or comments?

1-888-287-1915

Principal Display Panel

Compare to Ultra Strength Phazyme® Active Ingredient*

Ultra Strength

Gas Relief

Anti-Gas/Simethicone

Relief of:

• Gas discomfort
• Pressure
• Bloating

180 mg LIQUID-FILLED SOFTGELS

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR  72716  ©Wal-Mart Stores, Inc. Product of USA

*This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Ultra Strength Phazyme®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

EACH DOSE IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER UNIT IS TORN OR BROKEN.

Package Label

Equate Simethicone 180 mg Ultra Strength Gas Relief Softgels

 

INGREDIENTS AND APPEARANCE

GAS RELIEF  ULTRA STRENGTH
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-530
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)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	S180
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-530-20	2 in 1 CARTON	01/15/2013	12/31/2020
1		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	01/15/2013	12/31/2020

Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)

Registrant - P & L Development, LLC (079765031)