GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled 
Cardinal Health (Leader) 70000

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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Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antiflatulent (Antigas)

Use

Warnings

Stop use and ask a doctor if

condition persists.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

Directions

Other information

Inactive ingredients

FD&C red #40*,FD&C yellow # 6, gelatin, glycerin, purified water, white printing ink*

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO PHAZYME® ULTRA STRENGTH active ingredient**

Ultra Strength

Gas Relief

Simethicone, 180 mg | Antigas

For Relief of:

Gas

Pressure

Bloating

Discomfort

SOFTGELS

**This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme® Ultra Strength.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Package Label

Simethicone 180 mg

LEADER Ultra Strength Gas Relief

 

GAS RELIEF  ULTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0383
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
Colororange (Clear) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code S180;05A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0383-11 in 1 BOX11/09/201812/27/2024
160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33211/09/201812/27/2024
Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 10/2022
Document Id: b56c659e-47c3-4019-bbc1-54a1f98015dd
Set id: 342289cd-e4e3-4677-bcda-5aff3d7938b4
Version: 4
Effective Time: 20221020
 
Cardinal Health (Leader) 70000