FDA.reportPublic FDA data

Gencare-Gas Relief Simethicone 180 mg softgels

Manufacturer
PIONEER LIFE SCIENCES, LLC
Effective date
2026-08-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-07 01:01:13

Label at a glance#

ProductGencare-Gas Relief
Active ingredientDIMETHICONE
Label structure11 sections

Indications and uses

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

Dosage and administration

■ Swallow one or two soft gels as symptoms occur. ■ Do not exceed two soft gels per 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 180 mg

Purpose

OTC - PURPOSE SECTION

Anti-gas

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Stop use and ask a doctor if condition persisits.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Swallow one or two soft gels as symptoms occur.
■ Do not exceed two soft gels per 24 hours except under the advice and supervision of a physician.

Other information

OTHER SAFETY INFORMATION

■ store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow number 6, gelatin, glycerin, peppermint oil, sorbitol 70%, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call +1 (732) 994-2808 or email: support@gencare.health

SPL UNCLASSIFIED SECTION

†This product is neither manufactured nor distributed by C.B. Fleet Company, Inc. the owner of the registered trademark PHAZYME®

Distributed by: Gencare Consumer Products, LLC 40E Cotters Ln, Suite A, East Brunswick, NJ 08816 www.gencare.health

NDC 72090-073-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

L191-00 GC Gas Relief 180ctL191-00 GC Gas Relief 180ct

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72090-07372090-073-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
FD&C YELLOW NO. 6H77VEI93A8IACT
gelatin2G86QN327LIACT
glycerinPDC6A3C0OXIACT
peppermint oilAV092KU4JHIACT
SORBITOL SOLUTION8KW3E207O2IACT
titanium dioxide15FIX9V2JPIACT

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
Gencare-Gas ReliefSIMETHICONE 180 MGPIONEER LIFE SCIENCES, LLCb7f2d5db-c1b7-4c01-8ee6-017e4b9f14252026-08-04WarningsExact identifier
ndc (package): 72090-073-01
ndc (product): 72090-073
ndc11 (package): 72090007301
spl id: 32a53d60-e17f-4afd-a1d3-efe938a41713
spl set id: b7f2d5db-c1b7-4c01-8ee6-017e4b9f1425

Reported adverse events (FAERS/openFDA)#

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