ULTRA STRENGTH GAS RELIEF- simethicone capsule, liquid filled

Ultra Strength Gas Relief by

Drug Labeling and Warnings

Ultra Strength Gas Relief by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antiflatulent (Antigas)

Uses

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

Warnings

Stop use and ask a doctor if

condition persists.

If pregnant or breast-feeding,

ask a health professional before use.

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 15°-30°C (59°-86°F)

Inactive ingredients

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

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in Phazyme® Ultra Strength†

Ultra Strength

Gas Relief

Simethicone 180 mg

Anti-gas

Fast Relief of:

Pressure  Bloating  Discomfort

Softgels

Small, easy to swallow

†This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme®.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY  11590

Package Label

ReadyInCase Ultra Strength Gas Relief Softgel

INGREDIENTS AND APPEARANCE

ULTRA STRENGTH GAS RELIEF 
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59726-530
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE (ORANGE)	Score	no score
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	S180
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59726-530-10	1 in 1 BOX	09/01/2011
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	09/01/2011

Labeler - P & L Development, LLC (800014821)