LEADER GAS RELIEF- simethicone tablet, chewable

Leader Gas relief by

Drug Labeling and Warnings

Leader Gas relief by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH 110, LLC. DBA LEADER, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

LEADER GAS RELIEF 
simethicone tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0434
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	80 mg

Inactive Ingredients
Ingredient Name	Strength
SUGARCANE (UNII: 81H2R5AOH3)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	13mm
Flavor	PEPPERMINT	Imprint Code	G103
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0434-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part332	06/07/2019

Labeler - Cardinal Health (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(70000-0434)