ANTI-GAS ULTRA STRENGTH- simethicone capsule, liquid filled

Anti-Gas by

Drug Labeling and Warnings

Anti-Gas by is a Otc medication manufactured, distributed, or labeled by Freds 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)

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 15º-30ºC (59º-86ºF)

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

Anti-Gas

Ultra Strength

Simethicone, 180 mg

Provides Relief From Bloating, Pressure, Gas Discomfort

*Compare to the active ingredient in: Ultra Strength Phazyme®*

Softgels

DISTRIBUTED BY:  fred's, Inc.

4300 NEW GETWELL RD, MEMPHIS, TN  38118

www.fredsinc.com

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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Fred's Anti-Gas Ultra Strength Softgels

INGREDIENTS AND APPEARANCE

ANTI-GAS  ULTRA STRENGTH
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-530
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	CAPSULE	Size	12mm
Flavor		Imprint Code	S180
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-530-60	1 in 1 BOX	03/15/2013
1		60 in 1 BOTTLE; 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	03/15/2013

Labeler - Freds Inc (005866116)

Registrant - P & L Development, LLC (079765031)