FDA.reportPublic FDA data

Extra Strength Gas Relief

Manufacturer
Greenbrier International, Inc.
Effective date
2017-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:11

Label at a glance#

ProductExtra Strength Gas Relief
Active ingredientDIMETHICONE
Label structure8 sections

Dosage and administration

• adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime. • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician.

Storage and handling

• store at room temperature • protect from light, heat, and moisture

Label contents#

Full prescribing information#

Active ingredient (per each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

for the relief of

  • Pressure, bloating, and fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime.
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician.

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature
  • protect from light, heat, and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide

Questions or comments

OTC - QUESTIONS SECTION

1-866-467-2748

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength Gas Relief Simeticone ,125 mg Anti-Gas 15 Softgels
Extra Strength Gas Relief Simeticone ,125 mg Anti-Gas 15 Softgels

*Compare to the active ingredient in Extra Strength Gas-X®

Assured

Extra Strength

Gas Relief

SIMETHICONE, 125mg

ANTI-GAS

Relieves:

  • Bloating
  • Pressure
  • Fullness
  • Gas

    15 SOFTGELS

*This product is not manufactured or distributed by GSK Consumer Healthcare, Inc., the distributor of Gas-X® Extra strength.

Distributed by:

Greenbrier International, Inc.

Chesapeake, VA 23320

IMPORTANT: Keep this carton for future reference on full labeling.

DO NOT USE IF ANY INDIVIDUAL BLISTER IS BROKEN OR OPEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198852simethicone 125 MG Oral CapsulePSN1
198852simethicone 125 MG Oral CapsuleSCD1
198852dimethicone 125 MG Oral CapsuleSY1

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33992-3113-52020-01-31C16284748780-19d75b9d0-180d-f424-e053-dadaa90a57ceExtra Strength Gas Relief Simethicone, 125 mg Anti-Gas 15 Softgels

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33992-3113-5Extra Strength Gas Relief1 in 1 CARTONCAPSULE, LIQUID FILLED11
33992-3113-5Extra Strength Gas Relief15 in 1 BLISTER PACKCAPSULE, LIQUID FILLED151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-3113EXTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [GREENBRIER INTERNATIONAL, INC.]1Legacy NDC, 2 package rows20180119_b50bc466-9fd3-457c-8c7b-526b17ff8d1a.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
33992-311333992-3113-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
b50bc466-9fd3-457c-8c7b-526b17ff8d1ab50bc466-9fd3-457c-8c7b-526b17ff8d1a2017-12-21WarningsExact identifier
spl id: b50bc466-9fd3-457c-8c7b-526b17ff8d1a
spl set id: b50bc466-9fd3-457c-8c7b-526b17ff8d1a

Reported adverse events (FAERS/openFDA)#

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