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

60ct-bottle-lbl

Principal Display Panel

Cardinal Health - Leader

Maximum Strength

Gas Relief

Simethicone 250 mg (anti-gas)

60 Liquid Filled Softgels

Carton

NDC# 70000-0514-1

60ct-carton-lbl

GAS RELIEF
simethicone capsule, gelatin coated

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0514-1	1 in 1 CARTON	07/24/2019	09/30/2024
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M002	07/24/2019	09/30/2024

Labeler - Cardinal Health (063997360)

Registrant - Apotex Inc. (209429182)

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

Drug Facts

Active Ingredient

Purpose

Use

Warnings

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other Information

Inactive Ingredients

Questions?

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Principal Display Panel