FDA.reportPublic FDA data

Gencare-Nasal Decongestant PE

Manufacturer
Pioneer Life Sciences, LLC
Effective date
2025-02-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:55:42

Label at a glance#

ProductGencare-Nasal Decongestant PE
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Dosage and administration

take 1 tablet every 4 hours adults and children 12 years and over: do not take more than 6 tablets in 24 hours children under 12 years: ask a doctor

Storage and handling

store between 20-25°C (68-77°F) do not use if seal under cap is broken or missing

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 10mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

USES: 

INDICATIONS & USAGE SECTION

  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

WARNINGS

WARNINGS SECTION

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • heart disease
  • high blood pressure 
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland.

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever.

OTC - PREGNANCY OR BREAST FEEDING 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. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800 222-1222).

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

  • take 1 tablet every 4 hours
  • adults and children 12 years and over: do not take more than 6 tablets in 24 hours
  • children under 12 years: ask a doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F)
  • do not use if seal under cap is broken or missing

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Crosscarmellose Soidum, Dibasic Calcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Purified water. Readycoat Red contains: polyvinyl alcohol, polyethylene glycol, hypromellose, methacrylic acid copolymer, talc, titanium dioxide, allura red lake, indigo carmine lake.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0241-00 GC Nasal Decongestant 300ct_page-0001PL0241-00 GC Nasal Decongestant 300ct_page-0001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSN1
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-039-01Gencare-Nasal Decongestant PE300 in 1 BOTTLETABLET3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72090-039GENCARE-NASAL DECONGESTANT PE (PHENYLEPHRINE HYDROCHLORIDE) TABLET [PIONEER LIFE SCIENCES, LLC]1Current NDC, 1 package rows20250223_596ec923-56a0-4b6e-a69c-8d740feb75a2.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
72090-03972090-039-01

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
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
DICALCIUM PHOSPHATEL11K75P92JIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
POLYVINYL ALCOHOL532B59J990IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)74G4R6TH13IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
INDIGOTINDISULFONATE SODIUMD3741U8K7LIACT

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-Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLC596ec923-56a0-4b6e-a69c-8d740feb75a22025-02-20WarningsExact identifier
ndc (package): 72090-039-01
ndc (product): 72090-039
ndc11 (package): 72090003901
spl id: b1011774-c13a-48eb-8198-ef443472f5e6
spl set id: 596ec923-56a0-4b6e-a69c-8d740feb75a2

Reported adverse events (FAERS/openFDA)#

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