FDA.reportPublic FDA data

ValuMeds Nasal Decongestant PE Phenylephrine

Manufacturer
Cabinet Health P.B.C.
Effective date
2026-07-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-26 01:02:02

Label at a glance#

ProductValuMeds Nasal Decongestant PE Phenylephrine
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure9 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

 adults and children 12 years and over take 1 tablet every 4 hours 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 10 mg

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

OTC - DO NOT USE SECTION

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs fordepression, 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 a MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you hav

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

  • safety sealed: do not use if imprinted foil under bottle cap is opened or torn
  • store between 20°–25°C (68°–77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, D&C Yellow #10 Aluminium Lake, FD&C Blue #1, FD&C Red #40, Hypromellose, Magnesium stearate, Microcrystalline cellulose, Polyethylene glycol 400, Sodium starch glycolate, Starch 1500, Talc, Titanium dioxide

Questions?

OTC - QUESTIONS SECTION

Call 1-908-242-6108 Mon-Fri 8:00 AM to 5:00 PM EST

Package Labeling: 82725-1011-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ValuMeds Nasal Decongestant PE Phenylephrine HCl 10 mg, 300 tablets

LabelLabel

Package Labeling: 82725-1011-2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ValuMeds Nasal Decongestant PE Phenylephrine HCl 10 mg, 100 tablets

Label 2Label 2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850069928063GTIN-13: 0850069928063
EAN-13: 0850069928063
GTIN-12: 850069928063
UPC-A: 850069928063
GTIN storage (14 digits): 00850069928063		label 2.jpg

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82725-101182725-1011-1, 82725-1011-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
STARCH, CORNO8232NY3SJIACT
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
ValuMeds Nasal Decongestant PE PhenylephrinePHENYLEPHRINE HYDROCHLORIDECabinet Health P.B.C.3f284420-87c1-4c17-99e5-bc569bf9d45f2026-07-10WarningsExact identifier
ndc (package): 82725-1011-1
ndc (package): 82725-1011-2
ndc (product): 82725-1011
ndc11 (package): 82725101101
ndc11 (package): 82725101102
spl id: 5644bd60-9db9-e49a-e063-6394a90a3348
spl set id: 3f284420-87c1-4c17-99e5-bc569bf9d45f

Reported adverse events (FAERS/openFDA)#

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