LEADER GAS RELIEF EXTRA STRENGTH- simethicone 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.

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Cardinal Health Gas Relief Drug Facts

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

Gas Relief Carton

LEADER GAS RELIEF  EXTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-295
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGREENScoreno score
ShapeOVALSize10mm
FlavorImprint Code L428
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-295-653 in 1 CARTON07/18/2019
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33207/18/2019
Labeler - Cardinal Health (097537435)

Revised: 1/2021
Document Id: 30ca1059-88b6-4811-a4fd-e254118f11ae
Set id: 71ebf7f3-942d-4084-bec4-1b5c165857a1
Version: 4
Effective Time: 20210122
 
Cardinal Health