FDA.reportPublic FDA data

717T Albertsons 21130-717 Simethicone soft gelatin capsules 180 mg

Manufacturer
BETTER LIVING BRANDS, LLC | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-02-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:55:08

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?1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

717T-Albertsons-Simethicone180mg-60s-ifc717T-Albertsons-Simethicone180mg-60s-ifc

717T-Albertsons-Simethicone180mg-60s-label717T-Albertsons-Simethicone180mg-60s-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
21130-717-062025-02-12C16284748780-12cef2736-a7d4-d83d-e063-dadaa90ab31f717T Albertsons 21130-717 Simethicone soft gelatin capsules 180 mg
21130-717-062025-01-30C16284748780-12cef2736-a7d4-d83d-e063-dadaa90ab31f717T Albertsons 21130-717 Simethicone soft gelatin capsules 180 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-717-06Ultra Strength Gas Relief60 in 1 BOTTLECAPSULE603
21130-717-06Ultra Strength Gas Relief1 in 1 CARTONCAPSULE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-717ULTRA STRENGTH GAS RELIEF (SIMETHICONE) CAPSULE [BETTER LIVING BRANDS, LLC]3Current NDC, 2 package rows20250214_eb4bef2c-15dd-434a-e053-2a95a90a616f.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
21130-71721130-717-06

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
SORBITAN6O92ICV9RUIACT
SORBITOL SOLUTION8KW3E207O2IACT
GELATIN2G86QN327LIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
PEPPERMINT OILAV092KU4JHIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
SHELLAC46N107B71OIACT
DIMETHICONE92RU3N3Y1OACTIB
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT

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 ReliefSIMETHICONEBETTER LIVING BRANDS, LLCeb4bef2c-15dd-434a-e053-2a95a90a616f2025-02-12WarningsExact identifier
ndc (package): 21130-717-06
ndc (product): 21130-717
ndc11 (package): 21130071706
spl id: 2df04265-4a90-8001-e063-6294a90afcaa
spl set id: eb4bef2c-15dd-434a-e053-2a95a90a616f

Reported adverse events (FAERS/openFDA)#

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