OTC Medication Information: Leader Gas Relief Extra Strength

LEADER GAS RELIEF EXTRA STRENGTH- dimethicone capsule, liquid filled
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

Extra Strength Gas Relief 30 Softgels
(click image for full-size original)

Gas Relief Carton

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 125 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
GLYCERIN
PEPPERMINT OIL
WATER
TITANIUM DIOXIDE
Product Characteristics
Color GREEN Score no score
Shape OVAL Size 10mm
Flavor Imprint Code L428
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37205-295-65 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK This package is contained within the CARTON (37205-295-65)
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)

Revised: 01/2021 Cardinal Health

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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