FDA.reportPublic FDA data

Gas Relief

Manufacturer
Cardinal Health (Leader) 70000
Effective date
2022-10-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:51:09

Label at a glance#

ProductGas Relief Ultra Strength
Active ingredientDIMETHICONE
Label structure10 sections

Dosage and administration

swallow one or two softgels as needed after a meal do not exceed two softgels per day except under the advice and supervision of a physician

Storage and handling

store between 15º-30ºC (59º-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

Antiflatulent (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 care 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 needed after a meal
  • do not exceed two softgels per day except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40*,FD&C yellow # 6, gelatin, glycerin, purified water, white printing ink*

*contains one or more of these ingredients

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

For Relief of:

Gas

Pressure

Bloating

Discomfort

SOFTGELS

**This product is not manufactured or distributed by C.B. Fleet Company 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

www.myleader.com 1-800-200-6313

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER Ultra Strength Gas ReliefLEADER Ultra Strength Gas Relief 

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0383-1EA - Each70000-0383d3dc8ee4-81a8-4998-be63-d64422981d8912019-03-12

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
70000-038370000-0383-1

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
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT

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
b56c659e-47c3-4019-bbc1-54a1f98015dd342289cd-e4e3-4677-bcda-5aff3d7938b42022-10-20WarningsExact identifier
spl id: b56c659e-47c3-4019-bbc1-54a1f98015dd
spl set id: 342289cd-e4e3-4677-bcda-5aff3d7938b4

Reported adverse events (FAERS/openFDA)#

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