FDA.reportPublic FDA data

Walgreens Simethicone 250 mg Capsules Dye Free

Manufacturer
WALGREENS | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2024-03-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:10:26

Label at a glance#

ProductMaximum Strength Gas Relief
Active ingredientDIMETHICONE
Label structure9 sections

Storage and handling

Other information store at room temperature protect from light, heat and moisture

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each softgel)

Simethicone 250 mg

OTC - PURPOSE SECTION

Purpose

Antigas

INDICATIONS & USAGE SECTION

Usefor the relief of

  • pressure, bloating, and fullness commonly referred to as gas

Warning

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years and older: 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

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature
  • protect from light, heat and moisture

INACTIVE INGREDIENT SECTION

Inactive ingredients

ferrosoferric oxide, gelatin, glycerol, medium chain triglyceride, propylene glycol, purified water, shellac, sorbitol sorbitan solution

OTC - QUESTIONS SECTION

Questions or comments?Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

walgreens-simethicone-dyefree-30walgreens-simethicone-dyefree-30

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
412111simethicone 250 MG Oral CapsulePSN2
412111simethicone 250 MG Oral CapsuleSCD2
412111dimethicone 250 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
0363-9888-30Maximum Strength Gas Relief3 in 1 CARTONCAPSULE, LIQUID FILLED32
0363-9888-30Maximum Strength Gas Relief10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9888MAXIMUM STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [WALGREENS]2Current NDC, 2 package rows20240402_03bc9c99-2871-2604-e063-6394a90a2be5.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-98880363-9888-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERROSOFERRIC OXIDEXM0M87F357IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SHELLAC46N107B71OIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OACTIB
SORBITAN6O92ICV9RUIACT

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
Maximum Strength Gas ReliefSIMETHICONEWALGREENS03bc9c99-2871-2604-e063-6394a90a2be52024-03-06WarningsExact identifier
ndc (package): 0363-9888-30
ndc (product): 0363-9888
ndc11 (package): 00363988830
spl id: 12fa22ba-5b1d-74df-e063-6294a90a2368
spl set id: 03bc9c99-2871-2604-e063-6394a90a2be5

Reported adverse events (FAERS/openFDA)#

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