FDA.reportPublic FDA data

Nasal Decongestant PE

Manufacturer
VALU MERCHANDISERS COMPANY
Effective date
2024-12-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:47:38

Label at a glance#

ProductNasal Decongestant PE
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

store at 15°-25°C (59°-77°F) in a dry place retain carton for complete product information

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE 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

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by 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.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • store at 15°-25°C (59°-77°F) in a dry place
  • retain carton for complete product information

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, FD&C red #40, FD&C yellow #6, hypromellose, lactose anhydrous, magnesium stearate, polyethylene glycol, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO THE ACTIVE INGREDIENT IN SUDAFED PE® CONGESTION†

Best Choice®

Non-Drowsy

MAXIMUM STRENGTH

NASAL DECONGESTANT  PE

Actual Size

Phenylephrine HCl

For Relief of:

• Sinus Pressure

• Congestion

18 TABLETS

10 mg EACH

image descriptionimage description

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
63941-33163941-331-02, 63941-331-03

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
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 272LRS185U6KIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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
28728294-39fa-8c0b-e063-6394a90a95c253e6fa75-470f-4e92-aabf-ee16b779f65b2024-12-04WarningsExact identifier
spl id: 28728294-39fa-8c0b-e063-6394a90a95c2
spl set id: 53e6fa75-470f-4e92-aabf-ee16b779f65b

Reported adverse events (FAERS/openFDA)#

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