FDA.reportPublic FDA data

Gas Relief

Manufacturer
Pioneer Life Sciences, LLC
Effective date
2025-04-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:34

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure9 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

Label contents#

Full prescribing information#

Active ingredient (in 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

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

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

SPL UNCLASSIFIED SECTION

  • store at 15 to 30ºC (59 to 86ºF)
  • protect from light, heat, and moisture

Inactive Ingredients 

INACTIVE INGREDIENT SECTION

Refined Soyabean Oil, Gelatin, Glycerin, Sorbitol solution, Titanium dioxide, FD&C lue No 1, D&C Yellow 10, Purified water.

Questions or Comments?

OTC - QUESTIONS SECTION

Call + 1 (732) 994-2808 or email support@gencare.health

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0252-00 GC Gas Relief-125mg Extra Strength 180ct.jpgPL0252-00 GC Gas Relief-125mg Extra Strength 180ct.jpg

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-045-01Gas Relief180 in 1 BOTTLECAPSULE, LIQUID FILLED1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72090-045GAS RELIEF (SIMETHICONE 125 MG) CAPSULE, LIQUID FILLED [PIONEER LIFE SCIENCES, LLC]1Current NDC, 1 package rows20250425_21e11fe0-b3b9-42f6-a698-9cdc1a6d82bb.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
72090-04572090-045-01

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
HYDROGENATED SOYBEAN OILA2M91M918CIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
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
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC21e11fe0-b3b9-42f6-a698-9cdc1a6d82bb2025-04-23WarningsExact identifier
ndc (package): 72090-045-01
ndc (product): 72090-045
ndc11 (package): 72090004501
spl id: 588f048c-69c5-4f75-8764-bfd68f9ba286
spl set id: 21e11fe0-b3b9-42f6-a698-9cdc1a6d82bb

Reported adverse events (FAERS/openFDA)#

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