FDA.reportPublic FDA data

Simethicone

Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:42:15

Label at a glance#

ProductSimethicone
Active ingredientDIMETHICONE
Label structure11 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 180 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

DOSAGE & ADMINISTRATION SECTION

for the relief of
■ pressure and bloating commonly referred to as gas

Warnings

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

INDICATIONS & USAGE SECTION

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

Other information

OTHER SAFETY INFORMATION

■ store at controlled room temperature 20-25°C (68-77°F)
■ protect from heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow#6, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol solution, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252294simethicone 180 MG Oral CapsulePSN5
252294simethicone 180 MG Oral CapsuleSCD5
252294dimethicone 180 MG Oral CapsuleSY5

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
68210-4154-2Simethicone10 in 1 BLISTER PACKCAPSULE, GELATIN COATED105
68210-4154-2Simethicone2 in 1 CARTONCAPSULE, GELATIN COATED25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4154SIMETHICONE CAPSULE, GELATIN COATED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 2 package rows20241213_28cd4c11-6ce2-4cb8-b916-d6528fb63fa9.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-415468210-4154-2

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
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT
POVIDONE K30U725QWY32XIACT
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
290504c7-d131-ffc5-e063-6294a90a946028cd4c11-6ce2-4cb8-b916-d6528fb63fa92024-12-11WarningsExact identifier
spl id: 290504c7-d131-ffc5-e063-6294a90a9460
spl set id: 28cd4c11-6ce2-4cb8-b916-d6528fb63fa9

Reported adverse events (FAERS/openFDA)#

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