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 Freds Inc. 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 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.

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 between 15º-30ºC (59º-86ºF)
• protect from heat and moisture

Inactive ingredients

FD&C red #40*,FD&C yellow # 6, gelatin, glycerin, purified water, white printing ink*

*contains one or more of these ingredients

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

ANTIGAS SIMETHICONE 180 mg

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 PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: Fred's Inc.

4300 New Getwell Rd., Memphis , TN 38118

www.fredsinc.com

Package Label

FRED'S PHARMACY Ultra Strength Gas Relief

 

INGREDIENTS AND APPEARANCE

GAS RELIEF  ULTRA STRENGTH
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-832
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	S180;05A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-832-60	1 in 1 BOX	09/30/2018
1		60 in 1 BOTTLE, PLASTIC; 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	09/30/2018

Labeler - Freds Inc (005866116)