LEADER GAS RELIEF- simethicone tablet, chewable 
CARDINAL HEALTH 110, LLC. DBA LEADER

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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Leader Gas Relief Chewable Tablets

ACTIVE INGREDIENT(in each tablet)

Simethicone 80 mg

PURPOSE

Antigas

USE(S)

relieves:


  • pressure
  • bloating
  • symptoms referred to as gas

WARNINGS

.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center immediately. 

DIRECTIONS

  • chew 2 to 4 tablets thoroughly as needed after meals and at bedtime
  • do not exceed 6 tablets per day unless directed by a physician

OTHER INFORMATION

  • do  not use if inner seal is broken
  • store at room temperature
  • avoid high humidity and excessive heat, above 40oC (104oF)

INACTIVE INGREDIENTS

compressible sugar, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol.

PRINCIPAL DISPLAY PANEL

NDC 70000-0434-1
LEADER
Gas Relief

Simethicone, 80 mg
Antigas
Mint Flavor

For Relief of :
Pressure, Bloating, Symptoms Referred to as Gas

100 CHEWABLE TABLETS



119
LEADER GAS RELIEF 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0434
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
SUGARCANE (UNII: 81H2R5AOH3)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorPEPPERMINTImprint Code G103
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0434-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/07/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33206/07/2019
Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(70000-0434)

Revised: 1/2022
 
CARDINAL HEALTH 110, LLC. DBA LEADER