FDA.reportPublic FDA data

717T Kroger 41226-717 Simethicone capsules 180 mg

Manufacturer
KROGER COMPANY | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-02-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:52

Label at a glance#

ProductUltra Strength Gas Relief
Active ingredientDIMETHICONE
Label structure9 sections

Storage and handling

Other information • Store at room temperature

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each softgel)
Simethicone 180 mg

OTC - PURPOSE SECTION

Purpose
Anti-gas

INDICATIONS & USAGE SECTION

Uses
• Relieves bloating, pressure or fullness commonly referred to as gas.

WARNINGS SECTION

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctor if condition persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions
• Swallow one or two softgels as symptoms occur.
• Do not exceed two softgels per 24 hours except under the advice and supervision of a physician.

STORAGE AND HANDLING SECTION

Other information
• Store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients
FD&C Yellow No. 6, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments? Call 1-800-632-6900

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

717T-Simethicone-30s-ifc717T-Simethicone-30s-ifc

717T-Simethicone-30s-label717T-Simethicone-30s-label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252294simethicone 180 MG Oral CapsulePSN3
252294simethicone 180 MG Oral CapsuleSCD3
252294dimethicone 180 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
41226-717-302025-02-10C16284748780-12cef2736-6ff4-d83d-e063-dadaa90ab31f717T Kroger 41226-717 Simethicone capsules 180 mg
41226-717-302025-01-30C16284748780-12cef2736-6ff4-d83d-e063-dadaa90ab31f717T Kroger 41226-717 Simethicone capsules 180 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-717-30Ultra Strength Gas Relief1 in 1 CARTONCAPSULE13
41226-717-30Ultra Strength Gas Relief60 in 1 BOTTLECAPSULE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-717ULTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE [KROGER COMPANY]3Current NDC, 2 package rows20250212_ea1c4aa8-bde6-2072-e053-2995a90a93ba.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
41226-71741226-717-30

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
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SORBITOL SOLUTION8KW3E207O2IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT
SHELLAC46N107B71OIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
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
Ultra Strength Gas ReliefSIMETHICONEKROGER COMPANYea1c4aa8-bde6-2072-e053-2995a90a93ba2025-02-10WarningsExact identifier
ndc (package): 41226-717-30
ndc (product): 41226-717
ndc11 (package): 41226071730
spl id: 2dc8d457-2ae6-67a3-e063-6394a90a66f1
spl set id: ea1c4aa8-bde6-2072-e053-2995a90a93ba

Reported adverse events (FAERS/openFDA)#

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