FDA.reportPublic FDA data

Nasal Decongestant PE- Phenylephrine HCl 10 mg Tablet

Manufacturer
NUVICARE LLC
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:27:13

Label at a glance#

ProductNasal Decongestant PE
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

■ temporarily relieves sinus congestion and pressure ■ temporarily relieves nasal congestion due to 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

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 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.

Stope 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:

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENTS: 

INACTIVE INGREDIENT SECTION

Microcrystalline Cellulose, Dicalcium Phosphate, Croscarmellose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Polyvinyl Alcohol, Polyethylene Glycol, FD& Red #40/Allura Red AC Aluminum Lake, Talc, Titanium Dioxide

QUESTIONS OR COMMENTS ? 

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0209-00 NC Nasal Decongestant-100ctPL0209-00 NC Nasal Decongestant-100ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049182phenylephrine HCl 10 MG Oral TabletPSN2
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD2

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
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
84324-010-01Nasal Decongestant PE100 in 1 BOTTLETABLET1002

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
84324-01084324-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
TALC7SEV7J4R1UIACT
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
Nasal Decongestant PEPHENYLEPHRINE HCL 10 MGNUVICARE LLC4cde41dd-a0a7-45e7-aff3-ee9402dfdff22025-12-19WarningsExact identifier
ndc (package): 84324-010-01
ndc (product): 84324-010
ndc11 (package): 84324001001
spl id: 5869b99d-5cbb-41a1-a32a-82afd167d30e
spl set id: 4cde41dd-a0a7-45e7-aff3-ee9402dfdff2

Reported adverse events (FAERS/openFDA)#

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