LEADER GAS RELIEF ULTRA 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 180 mg

Purpose

Anti-gas

Uses

•
relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

condition persists

Keep out of reach of children.

Directions

•
swallow one or two softgels as needed after a meal
•
do not exceed two softgels per day except under the advice and supervision of a physician

Other information

•
each softgel contains: potassium 5 mg
•
store at 68°-77°F (20°-25°C)

Inactive ingredients

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Phazyme® Ultra Strength active ingredient

Ultra Strength

Gas Relief

Anti-Gas/Simethicone 180 mg

Fast Relief

Relieves Gas - Pressure

Bloating - Gas Discomfort

Easy to Swallow

Actual Size

Gas Relief Carton

Gas Relief Carton

Gas Relief Carton

LEADER GAS RELIEF  ULTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-292
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize9mm
FlavorImprint Code L657
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-292-721 in 1 CARTON03/04/200209/30/2020
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33203/04/200209/30/2020
Labeler - Cardinal Health (097537435)

Revised: 12/2018
Document Id: 4a0c65ff-70cd-4f60-93ed-09d62ec51352
Set id: cfd92a78-926a-4856-af13-7bcc80d514cd
Version: 2
Effective Time: 20181213
 
Cardinal Health