FDA.reportPublic FDA data

Gas Relief

Manufacturer
NUVICARE LLC
Effective date
2025-04-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:35

Label at a glance#

ProductGas Relief
Active ingredientDIMETHICONE
Label structure9 sections

Dosage and administration

adults : 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

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 125 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

For the relief of pressure, bloating, and fullness, commonly referred to as gas.

Warnings

WARNINGS SECTION

If pregnant or breast-feeding, ask a health Professional before use .

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults : 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

Other Information

SPL UNCLASSIFIED SECTION

  • store at 15 to 30ºC (59 to 86ºF)
  • protect from light, heat, and moisture

Inactive Ingredients 

INACTIVE INGREDIENT SECTION

Refined Soyabean Oil, Gelatin, Glycerin, Sorbitol solution, Titanium dioxide, FD&C lue No 1, D&C Yellow 10, Purified water.

Questions or Comments?

OTC - QUESTIONS SECTION

Call + 1 (718) 337-8733 or visit: support@nuvicare.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0254-00 NC-Gas Relief 125mg-100ctPL0254-00 NC-Gas Relief 125mg-100ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198852simethicone 125 MG Oral CapsulePSN1
198852simethicone 125 MG Oral CapsuleSCD1
198852dimethicone 125 MG Oral CapsuleSY1

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
84324-022-01Gas Relief100 in 1 BOTTLECAPSULE, LIQUID FILLED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84324-022GAS RELIEF (SIMETHICONE 125 MG) CAPSULE, LIQUID FILLED [NUVICARE LLC]1Current NDC, 1 package rows20250425_5c6352b9-fd8a-4876-b089-e4c1d15cd264.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84324-02284324-022-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
HYDROGENATED SOYBEAN OILA2M91M918CIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
WATER059QF0KO0RIACT

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
Gas ReliefSIMETHICONE 125 MGNUVICARE LLC5c6352b9-fd8a-4876-b089-e4c1d15cd2642025-04-23WarningsExact identifier
ndc (package): 84324-022-01
ndc (product): 84324-022
ndc11 (package): 84324002201
spl id: a931f76f-941d-4129-8bfa-ae23c58d8357
spl set id: 5c6352b9-fd8a-4876-b089-e4c1d15cd264

Reported adverse events (FAERS/openFDA)#

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