FDA.reportPublic FDA data

CVS_721T_51316-621_Simethicone Soft Gelatin Capsules 180 mg

Manufacturer
CVS PHARMACY, INC | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-01-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:54:06

Label at a glance#

ProductUltrastrength Gas Relief
Active ingredientDIMETHICONE
Label structure9 sections

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

Use for the relief of

  • pressure and bloating 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: 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

OTHER SAFETY INFORMATION

Other information

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

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 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS_721T_50ctCVS_721T_50ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252294simethicone 180 MG Oral CapsulePSN2
252294simethicone 180 MG Oral CapsuleSCD2
252294dimethicone 180 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
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
51316-621-76Ultrastrength Gas Relief10 in 1 BLISTER PACKCAPSULE102
51316-621-76Ultrastrength Gas Relief5 in 1 CARTONCAPSULE52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-621ULTRASTRENGTH GAS RELIEF (SIMETHICONE SOFT GELATIN CAPSULES) CAPSULE [CVS PHARMACY, INC]2Current NDC, 2 package rows20250201_24ceba32-eb30-902f-e063-6394a90a9fd5.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
51316-62151316-621-76

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
SHELLAC46N107B71OIACT
DIMETHICONE92RU3N3Y1OACTIB
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT
SORBITAN6O92ICV9RUIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
GELATIN2G86QN327LIACT

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
Ultrastrength Gas ReliefSIMETHICONE SOFT GELATIN CAPSULESCVS PHARMACY, INC24ceba32-eb30-902f-e063-6394a90a9fd52025-01-29WarningsExact identifier
ndc (package): 51316-621-76
ndc (product): 51316-621
ndc11 (package): 51316062176
spl id: 2b082a35-29b6-345e-e063-6394a90a6246
spl set id: 24ceba32-eb30-902f-e063-6394a90a9fd5

Reported adverse events (FAERS/openFDA)#

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