FDA.reportPublic FDA data

Leader Gas Relief Chewable Tablets

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER | Guardian Drug Company
Effective date
2024-12-17
Label type
Human OTC Drug Label
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:05

Label at a glance#

ProductLeader Gas relief
Active ingredientDIMETHICONE
Label structure9 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 80 mg

PURPOSE

OTC - PURPOSE SECTION

Antigas

USE(S)

INDICATIONS & USAGE SECTION

relieves:


  • pressure
  • bloating
  • symptoms referred to as gas

WARNINGS

WARNINGS SECTION

.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DC 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

119119

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314216simethicone 80 MG Chewable TabletPSN4
314216simethicone 80 MG Chewable TabletSCD4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0434-1Leader Gas relief100 in 1 BOTTLETABLET, CHEWABLE1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0434LEADER GAS RELIEF (SIMETHICONE) TABLET, CHEWABLE [CARDINAL HEALTH 110, LLC. DBA LEADER]4Current NDC, Legacy NDC, 1 package rows20241219_0163d372-222e-4a8d-a5cb-5a7af9a7068c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0434-1EA - Each70000-0434174f7308-4ae5-4154-b2ff-8645a2a0330912020-03-10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-043470000-0434-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
SUGARCANE81H2R5AOH3IACT
MALTODEXTRIN7CVR7L4A2DIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Gas reliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER0163d372-222e-4a8d-a5cb-5a7af9a7068c2024-12-17WarningsExact identifier
ndc (package): 70000-0434-1
ndc (product): 70000-0434
ndc11 (package): 70000043401
spl id: c598e7be-e58f-4812-8a05-f03d9303053b
spl set id: 0163d372-222e-4a8d-a5cb-5a7af9a7068c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.