FDA.reportPublic FDA data

Leader Gas Relief Chewable Tablets

Manufacturer
REMEDYREPACK INC.
Effective date
2022-09-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:52:45

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 40 oC (104 oF)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Leader Gas relief

GENERIC: Simethicone

DOSAGE: TABLET, CHEWABLE

ADMINSTRATION: ORAL

NDC: 70518-3325-0

NDC: 70518-3325-1

NDC: 70518-3325-2

COLOR: white

FLAVOR: PEPPERMINT

SHAPE: ROUND

SCORE: No score

SIZE: 13 mm

IMPRINT: G103

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

  • DIMETHICONE 80mg in 1

INACTIVE INGREDIENT(S):

  • SUGARCANE
  • MALTODEXTRIN
  • DEXTROSE, UNSPECIFIED FORM
  • MAGNESIUM STEARATE
  • MICROCRYSTALLINE CELLULOSE
  • SORBITOL

MM1MM1

MM2MM2

MM3MM3

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
70518-332570518-3325-0, 70518-3325-2, 70518-3325-1
70000-0434

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
SUGARCANE81H2R5AOH3IACT
MALTODEXTRIN7CVR7L4A2DIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SORBITOL506T60A25RIACT
DIMETHICONE92RU3N3Y1OACTIB

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 · 2 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 (product): 70000-0434
07d815ea-858f-ea8f-e063-6294a90ac84de3a218f5-d1fa-418e-987a-58aa811f94e02023-10-16WarningsExact identifier
spl set id: e3a218f5-d1fa-418e-987a-58aa811f94e0

Reported adverse events (FAERS/openFDA)#

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