Gas Relief

Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:43:19

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

for the relief of • pressure, bloating, and fullness commonly referred to as gas

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 controlled room temperature 20-25°C (68-77°F) • protect from light, heat, and moisture

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

for the relief of • pressure, bloating, and fullness commonly referred to as gas

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 controlled room temperature 20-25°C (68-77°F)
• protect from light, heat, and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue No. 1, FD&C Yellow No. 10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

Distributed by:

SPL UNCLASSIFIED SECTION

Cabinet Health P.B.C.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Simethicone 125 mg JarSimethicone 125 mg Jar

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198852simethicone 125 MG Oral CapsulePSN4
198852simethicone 125 MG Oral CapsuleSCD4
198852dimethicone 125 MG Oral CapsuleSY4

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
68210-4222-82026-01-29C16284748780-149896155-ae11-586f-e063-e6dba90add90Gas Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4222-8Gas Relief82 in 1 JARCAPSULE, LIQUID FILLED824

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4222GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]4Legacy NDC, 1 package rows20241215_7b055389-c038-400d-8c74-ad8fde701fb3.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
68210-422268210-4222-8

Ingredients#

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

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

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
292e2215-bd6c-7983-e063-6394a90aa5757b055389-c038-400d-8c74-ad8fde701fb32024-12-13WarningsExact identifier
spl id: 292e2215-bd6c-7983-e063-6394a90aa575
spl set id: 7b055389-c038-400d-8c74-ad8fde701fb3

Reported adverse events (FAERS/openFDA)#

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