FDA.reportPublic FDA data

Maximum Strength Gas Relief Softgel

Manufacturer
Cardinal Health 110, LLC. DBA Leader
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:07:08

Label at a glance#

ProductMaximum Strength Gas Relief Softgel
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

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

Dosage and administration

• Swallow one or two softgels as symptoms occur • do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician

Storage and handling

• store at room temperature 20-25°C (68-77°F) • protect from heat, humidity and light

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Stop use and ask a doctor if condition persists.

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

• Swallow one or two softgels as symptoms occur
• do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

• store at room temperature 20-25°C (68-77°F)
• protect from heat, humidity and light

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red #33, edible ink, FD&C blue #1, gelatin, glycerin, purified water

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Monday- Friday 8am - 4pm EST

SPL UNCLASSIFIED SECTION

LEADER™

Relieves:
  Bloating
  Pressure
  Fullness

COMPARE TO PHAZYME® MAXIMUM STRENGTH active ingredient*

100% Money Back Guarantee 

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS CUT TORN OR MISSING

*This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme® Maximum Strength.

DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com
1-800-200-6313

©2023 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal Health. All other marks are the property of their respective owners.

Product of United Arab Emirates

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cardnl-antigas-0632Cardnl-antigas-0632

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
412111simethicone 250 MG Oral CapsulePSN4
412111simethicone 250 MG Oral CapsuleSCD4
412111dimethicone 250 MG Oral CapsuleSY4

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0632-1Maximum Strength Gas Relief Softgel60 in 1 BOTTLECAPSULE, LIQUID FILLED604
70000-0632-1Maximum Strength Gas Relief Softgel1 in 1 CARTONCAPSULE, LIQUID FILLED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0632MAXIMUM STRENGTH GAS RELIEF SOFTGEL (SIMETHICONE) CAPSULE, LIQUID FILLED [CARDINAL HEALTH 110, LLC. DBA LEADER]4Current NDC, 2 package rows20240113_57043cae-a8db-4eff-835c-5995e8aea924.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-063270000-0632-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

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
Maximum Strength Gas Relief SoftgelSIMETHICONECardinal Health 110, LLC. DBA Leader57043cae-a8db-4eff-835c-5995e8aea9242024-01-11WarningsExact identifier
ndc (package): 70000-0632-1
ndc (product): 70000-0632
ndc11 (package): 70000063201
spl id: fc6d5705-4d9a-4170-81ba-3ba12d99ace7
spl set id: 57043cae-a8db-4eff-835c-5995e8aea924

Reported adverse events (FAERS/openFDA)#

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