FDA.reportPublic FDA data

728T Target 11673-827 Simethicone 250 mg Capsules

Manufacturer
TARGET CORPORATION | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2024-05-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:12:50

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

Use for 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

D&C red no. 33, FD&C blue 1, gelatin, glycerol, medium chain triglyceride, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? Call 1-800-910-6874

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

simethicone-250mg-50s-labelsimethicone-250mg-50s-label728T-TG-Simethicone-30-IFC728T-TG-Simethicone-30-IFC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
412111simethicone 250 MG Oral CapsulePSN3
412111simethicone 250 MG Oral CapsuleSCD3
412111dimethicone 250 MG Oral CapsuleSY3

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
11673-827-30Maximum Strength Gas Relief3 in 1 CARTONCAPSULE, LIQUID FILLED33
11673-827-30Maximum Strength Gas Relief10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED103
11673-827-76Maximum Strength Gas Relief5 in 1 CARTONCAPSULE, LIQUID FILLED53
11673-827-76Maximum Strength Gas Relief10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-827MAXIMUM STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [TARGET CORPORATION]3Current NDC, 4 package rows20240522_f6ff50f5-4195-a61f-e053-6294a90a8bdf.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-82711673-827-30, 11673-827-76

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
SORBITAN6O92ICV9RUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SHELLAC46N107B71OIACT
D&C RED NO. 339DBA0SBB0LIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT

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 ReliefSIMETHICONETARGET CORPORATIONf6ff50f5-4195-a61f-e053-6294a90a8bdf2024-05-13WarningsExact identifier
ndc (package): 11673-827-30
ndc (package): 11673-827-76
ndc (product): 11673-827
ndc11 (package): 11673082730
ndc11 (package): 11673082776
spl id: 185651e7-8f06-5ce0-e063-6394a90a9ff5
spl set id: f6ff50f5-4195-a61f-e053-6294a90a8bdf

Reported adverse events (FAERS/openFDA)#

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