FDA.reportPublic FDA data

Extra Strength Gas Relief

Manufacturer
TARGET CORPORATION | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-01-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:55:09

Label at a glance#

ProductExtra 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 125 mg

OTC - PURPOSE SECTION

Purpose

Anti-gas

INDICATIONS & USAGE SECTION

Use for the relief of

  • pressure, bloating and fullness commonly referred to as gas

WARNINGS SECTION

Warning

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 4 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 Yellow #10, FD&C Blue 1, FD&C Red #40, gelatin, glycerol, medium chain triglyceride, peppermint oil, 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

722T- Target Extra strength gas relief- 72ct722T- Target Extra strength gas relief- 72ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198852simethicone 125 MG Oral CapsulePSN3
198852simethicone 125 MG Oral CapsuleSCD3
198852dimethicone 125 MG Oral CapsuleSY3

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
11673-495-712025-02-12C16284748780-12cef2736-7dce-d83d-e063-dadaa90ab31f722T Target 11673-495 Simethicone 125 mg softgels
11673-495-712025-01-30C16284748780-12cef2736-7dce-d83d-e063-dadaa90ab31f722T Target 11673-495 Simethicone 125 mg softgels

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-495-71Extra Strength Gas Relief3 in 1 CARTONCAPSULE, LIQUID FILLED33
11673-495-71Extra Strength Gas Relief24 in 1 BLISTER PACKCAPSULE, LIQUID FILLED243

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-495EXTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [TARGET CORPORATION]3Current NDC, 2 package rows20250214_f6ff3b61-8a47-14ec-e053-6294a90a2df8.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-49511673-495-71

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
FD&C RED NO. 40WZB9127XOAIACT
PEPPERMINT OILAV092KU4JHIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
WATER059QF0KO0RIACT
SHELLAC46N107B71OIACT
SORBITAN6O92ICV9RUIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
Extra Strength Gas ReliefSIMETHICONETARGET CORPORATIONf6ff3b61-8a47-14ec-e053-6294a90a2df82025-01-31WarningsExact identifier
ndc (package): 11673-495-71
ndc (product): 11673-495
ndc11 (package): 11673049571
spl id: 2cfa8079-450b-d42c-e063-6394a90a424c
spl set id: f6ff3b61-8a47-14ec-e053-6294a90a2df8

Reported adverse events (FAERS/openFDA)#

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