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Drug Facts

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Effective date
2026-07-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-18 05:10:14

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure10 sections

Dosage and administration

swallow one or two softgels as symptoms occur do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Storage and handling

store between 15-30ºC (59-86ºF) protect from heat and moisture

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 180 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

  • relieves bloating, pressure, or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow one or two softgels as symptoms occur
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

  • store between 15-30ºC (59-86ºF)
  • protect from heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO PHAZYME® ULTRA STRENGTH active ingredient*

Ultra Strength

Gas Relief

Simethicone, 180 mg

Antigas

fast relief of:

  • Gas
  • Pressure
  • Bloating
  • Discomfort

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER Ultra Strength Gas Relief
LEADER Ultra Strength Gas Relief

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295143362GTIN-13: 0096295143362
EAN-13: 0096295143362
GTIN-12: 096295143362
UPC-A: 096295143362
GTIN storage (14 digits): 00096295143362		gas-relief-180-mg-softgel-pur-1.jpg

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-066870000-0668-1
51013-115

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-03-04full-release2026-06-01 00:09:21

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
Gas ReliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER 70000cce7f7db-99b8-4d7d-ac77-43da6323ebe12026-07-14WarningsExact identifier
ndc (package): 70000-0668-1
ndc (product): 70000-0668
ndc11 (package): 70000066801
spl id: 8aafe1ce-c032-4e21-bb6d-97dbe562d72f
spl set id: cce7f7db-99b8-4d7d-ac77-43da6323ebe1

Reported adverse events (FAERS/openFDA)#

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