EXTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled

Extra Strength Gas Relief by

Drug Labeling and Warnings

Extra Strength Gas Relief by is a Otc medication manufactured, distributed, or labeled by Shopko Stores Operating Co., LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antiflatulent

Uses

for relief of:

• bloating
• pressure
• fullness
• stuffed feeling commonly referred to as gas

Warnings

Stop use 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

• adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime. Do not exceed 4 softgels per day, unless directed by a doctor.

Other information

• store at controlled room temperature 15o- 30o C (59o- 86o F)
• protect from heat and moisture
• *This product is not manufactured or distributed by Novartis Consumer Healthcare Inc., owner of the registered trademark Extra Strength Gas-X®.

Inactive ingredients

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil and titanium dioxide. May also contain: purified water and sorbitol special.

principal display panel

 Extra Strength Gas Relief

ANTIGAS

SIMETHICONE 125 mg

Relieves:

• bloating
• pressure
• fullness
• gas

*Compare to  Extra Strength Gas-X® active ingredient

Packaged by: PL Developments

200 hicks street

westbury, NY 11590 USA

QUESTIONS OR COMMENTS?

call toll free 1-877-753-3935

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

Product Label

SIMETHICONE 125 MG

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37012-550
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	PO
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37012-550-30	2 in 1 CARTON
1		15 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part332	06/02/2010

Labeler - Shopko Stores Operating Co., LLC. (023252638)