GAS RELIEF- simethicone capsule, gelatin coated

Gas Relief by

Drug Labeling and Warnings

Gas Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Apotex Inc., Catalent Ontario Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

(in each softgel)

Simethicone 250mg

Purpose

Anti-gas

Use

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

Stop use and ask a doctor if condition persists

Keep out of reach of children.

Directions

• swallow one or two softgels as symptoms occur
• do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information

• store at room temperature 15ºC to 30ºC (59ºF to 86ºF)

Inactive Ingredients

DC Red # 33, FD&C Blue No. 1, Gelatin, Glycerin, purified water, titanium dioxide

Questions?

Call toll-free 1-800-706-5575

Principal Display Panel

Cardinal Health - Leader

Maximum Strength

Gas Relief

Simethicone 250 mg (anti-gas)

60 Liquid Filled Softgels

Bottle label

NDC# 70000-0514-1

Principal Display Panel

Cardinal Health - Leader

Maximum Strength

Gas Relief

Simethicone 250 mg (anti-gas)

60 Liquid Filled Softgels

Carton

NDC# 70000-0514-1

INGREDIENTS AND APPEARANCE

GAS RELIEF 
simethicone capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0514
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	250 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
WATER (UNII: 059QF0KO0R)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	purple	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0514-1	1 in 1 CARTON	07/24/2019
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	07/24/2019

Labeler - Cardinal Health (097537435)

Registrant - Apotex Inc. (209429182)

Establishment
Name	Address	ID/FEI	Business Operations
Catalent Ontario Limited		248441727	analysis(70000-0514) , manufacture(70000-0514)