ASSURED GAS RELIEF EXTRA STRENGTH EXTRA STRENGTH- simethicone capsule, liquid filled

Assured Gas Relief Extra Strength by

Drug Labeling and Warnings

Assured Gas Relief Extra Strength by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

for the relief of

• pressure, bloating, and fullness commonly referred to as gas

Warnings

Keep out of reach of children

Directions

• Adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
• do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
• do not use if any individual blister unit is broken or missing

Other information

• store at controlled room temperature 20°-25°C (68-77°F)
• protect from light, heat and moisture

Inactive ingredients

D&C yellow 10, FD&C blue 1, gelatin, glycerin, purified water, titanium dioxide

Principal Display Panel

Compare to active ingredient in Extra Strength Gas-X®

Extra Strength

Gas Relief

Simethicone 125 mg

Anti-Gas

Relieves:

Bloating, Pressure, Fullness, Gas

15 Softgels

Assured Gas Relief Extra Strength

INGREDIENTS AND APPEARANCE

ASSURED GAS RELIEF EXTRA STRENGTH  EXTRA STRENGTH
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-0113
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)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	R113
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-0113-1	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	01/06/2012

Labeler - Greenbrier International, Inc. (610322518)