FDA.reportPublic FDA data

Maximum Strength 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 00:43:31

Label at a glance#

ProductMaximum Strength Gas Relief
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

relives bloating, pressure or fullness commonly referred to as gas

Dosage and administration

• Swallow one or two softgels after a mea • do not exceed two softgels in 24 hours except under the advice and supervision of a physician

Storage and handling

• store at room temperature 59-86°F (15-30°C)

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

relives bloating, pressure or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Stop use and ask a doctor if condition persists

Directions

DOSAGE & ADMINISTRATION SECTION

• Swallow one or two softgels after a mea • do not exceed two softgels in 24 hours except under the advice and supervision of a physician

Other Information

STORAGE AND HANDLING SECTION

• store at room temperature 59-86°F (15-30°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C Red #33, FD&C Blue #1, gelatin, glycerin, povidone, purified water, sorbitol solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

Distributed by:

SPL UNCLASSIFIED SECTION

Rite Aid
30 Hunter Lane, Camp Hill, Pa 17011

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Simethicone 250 mg JarSimethicone 250 mg Jar

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
68210-4223-4Maximum Strength Gas Relief40 in 1 JARCAPSULE, LIQUID FILLED404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4223MAXIMUM STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]4Legacy NDC, 1 package rows20241215_b514b796-fea5-460c-8b4f-8c6503a41a69.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
68210-422368210-4223-4

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
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POVIDONEFZ989GH94EIACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION8KW3E207O2IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIMETHICONE92RU3N3Y1OACTIB

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
292d94e8-1f88-8e61-e063-6394a90af115b514b796-fea5-460c-8b4f-8c6503a41a692024-12-13WarningsExact identifier
spl id: 292d94e8-1f88-8e61-e063-6394a90af115
spl set id: b514b796-fea5-460c-8b4f-8c6503a41a69

Reported adverse events (FAERS/openFDA)#

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