LEADER GAS RELIEF EXTRA STRENGTH- simethicone capsule, liquid filled

Leader Gas Relief by

Drug Labeling and Warnings

Leader Gas Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Simethicone 125 mg

Purpose

Antigas

Uses

relieves pressure and bloating commonly referred to as gas

Warnings

Keep out of reach of children

Directions

• do not exceed 4 softgels in 24 hours
• adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime

Other information

store at 20°-25°C

Inactive ingredients

D&C yellow #10, FD&C blue #1, FD&C red #40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

NDC: 37205-295-65

Compare to Gas-X® Extra Strength active ingredient*

EXTRA STRENGTH

Gas Relief

Simethicone 125 mg

Anti-Gas

For Fast Relief of Pressure, Bloating & Discomfort

SATISFACTION GUARANTEED

30 SOFTGEL

IMPORTANT: Keep this carton for future reference on full labeling.

Distributed By: Cardinal Health

Dublin Ohio 43017

www.myleader.com

CIN 2788362

All Leader® Brand products are 100% satisfaction guaranteed or return to place of purchase for a full refund.

*This product is not manufactured or distributed by GSK Consumer Healthcare, Inc. the distributor of Gas-X® Extra Strength.

Gas Relief Carton

INGREDIENTS AND APPEARANCE

LEADER GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-295
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Inactive Ingredients
Ingredient Name	Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	GREEN	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	L428
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-295-65	3 in 1 CARTON	07/18/2019
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	07/18/2019

Labeler - Cardinal Health (097537435)