FDA.reportPublic FDA data

Gas Relief Simethicone 125mg Softgel

Manufacturer
NUVICARE LLC
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:27:22

Label at a glance#

ProductGas Relief Simethicone 125mg Softgel
Active ingredientDIMETHICONE
Label structure10 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

Use 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

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

OTHER SAFETY INFORMATION

  • store at 15° to 30°C (59° to 86°F)
  • protect from light, heat, and moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Peppermint Oil, Gelatin, Sorbitol,  Sorbitan Anhydrous, Glycerin, FD & C blue 1 (Brilliant Blue FCF), Titanium Dioxide, D & C Yellow 10 (Quinoline Yellow).

Questions or Comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0213-00 NC-Gas Relief 125mg-100ct.jpgPL0213-00 NC-Gas Relief 125mg-100ct.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198852simethicone 125 MG Oral CapsulePSN2
198852simethicone 125 MG Oral CapsuleSCD2
198852dimethicone 125 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130384324000121GTIN-13: 0384324000121
EAN-13: 0384324000121
GTIN-12: 384324000121
UPC-A: 384324000121
GTIN storage (14 digits): 00384324000121		PL0213-00 NC-Gas Relief 125mg-100ct.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84324-014-01Gas Relief Simethicone 125mg Softgel100 in 1 BOTTLECAPSULE, LIQUID FILLED1002

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
84324-01484324-014-01

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
PEPPERMINT OILAV092KU4JHIACT
GELATIN2G86QN327LIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT
GLYCERINPDC6A3C0OXIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
D&C YELLOW NO. 1035SW5USQ3GIACT

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 Relief Simethicone 125mg SoftgelSIMETHICONENUVICARE LLCb774c8e6-e68e-4a13-834d-7eba34c5c3e02025-12-19WarningsExact identifier
ndc (package): 84324-014-01
ndc (product): 84324-014
ndc11 (package): 84324001401
spl id: 5b5f1c15-7b17-42be-b068-804e60596153
spl set id: b774c8e6-e68e-4a13-834d-7eba34c5c3e0

Reported adverse events (FAERS/openFDA)#

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