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

----------

Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antigas

Use

Warnings

Stop use and ask a doctor if

condition persists.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

Other information

Inactive ingredients

FD&C yellow #6, gelatin, glycerin, water

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

fast relief of:

Softgels

*This product is not manufactured or distributed by Prestige Consumer Healthcare, 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

Product Label

Simethicone 180 mg

LEADER Ultra Strength Gas Relief

GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0668(NDC:51013-115)
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)  
Product Characteristics
Colororange (clear) Scoreno score
ShapeCAPSULE (oval) Size10mm
FlavorImprint Code PC3
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0668-11 in 1 BOX03/01/2024
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 DrugM00203/01/2024
Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 3/2024
Document Id: a6caaa17-39d9-4795-b185-cf67b7565e1d
Set id: cce7f7db-99b8-4d7d-ac77-43da6323ebe1
Version: 1
Effective Time: 20240304
 
Cardinal Health (Leader) 70000