FDA.reportPublic FDA data

Simethicone

Manufacturer
PURACAP PHARMACEUTICAL LLC
Effective date
2019-03-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:58

Label at a glance#

ProductSimethicone
Active ingredientDIMETHICONE
Label structure10 sections

Indications and uses

relieves bloating, pressure or fullness commonly referred to as gas

Dosage and administration

▪ swallow one or two softgels after a meal ▪ do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Simethicone 250 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

relieves bloating, pressure or fullness commonly referred to as gas

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

condition persists

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow one or two softgels after a meal
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician

Other Information

OTHER SAFETY INFORMATION

  • 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, purified water and white edible ink

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-855-215-8180

Package/Label Principal Display Panel – Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MS Gas Relief-Simeth 250mg.jpg
MS Gas Relief-Simeth 250mg.jpg

Package/Label Principal Display Panel – Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MS Gas Relief-Simeth 250mg.jpg
MS Gas Relief-Simeth 250mg.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
412111simethicone 250 MG Oral CapsulePSN1
412111simethicone 250 MG Oral CapsuleSCD1
412111dimethicone 250 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
51013-439-022025-01-30C16284748780-12cef2736-74a7-d83d-e063-dadaa90ab31fMAXIMUM STRENGTH GAS RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-439-02Simethicone1 in 1 CARTONCAPSULE, LIQUID FILLED11
51013-439-02Simethicone12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-439SIMETHICONE CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]1Legacy NDC, 2 package rows20190325_9b4d1bff-55f1-4f86-a9dd-bcc7ad39e763.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51013-43951013-439-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
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
9b4d1bff-55f1-4f86-a9dd-bcc7ad39e7639b4d1bff-55f1-4f86-a9dd-bcc7ad39e7632019-03-22WarningsExact identifier
spl id: 9b4d1bff-55f1-4f86-a9dd-bcc7ad39e763
spl set id: 9b4d1bff-55f1-4f86-a9dd-bcc7ad39e763

Reported adverse events (FAERS/openFDA)#

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