FDA.reportPublic FDA data

Decongestant PE

Manufacturer
Harmon Store Inc. | LNK International, Inc.
Effective date
2022-10-10
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 21:51:56

Label at a glance#

ProductDecongestant 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 temporarily relieves sinus congestion and pressure 

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 

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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
  • diabetes
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to enlargement of the 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 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 (1-800-222-1222) right away. 

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

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide 

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CORE VALUES™

Compare to active
ingredient in Sudafed PE®
Congestion†

NDC 63940-453-44

Decongestant PE
Phenylephrine HCl 10 mg

Nasal Decongestant
Non-Drowsy

• Sinus Pressure
• Congestion

Actual Size

18 tablets

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed by: Liberty Procurement Inc.,
650 Liberty Ave., Union, NJ 07083 U.S.A.
Satisfaction Guaranteed Or Your Money Back
Visit us at www.facevalues.com

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Congestion.

 50844         ORG071545344
Core Values 44-453Core Values 44-453

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63940-45363940-453-44, 63940-453-03

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 HYDROCHLORIDE04JA59TNSJACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DEXTROSE MONOHYDRATELX22YL083GIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C RED NO. 40WZB9127XOAIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
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
985b9197-07ea-4efd-a1a6-e4cfdf3a7cd1cd83e4a6-8653-4706-a01b-fd4af4ee26d72022-10-10WarningsExact identifier
spl id: 985b9197-07ea-4efd-a1a6-e4cfdf3a7cd1
spl set id: cd83e4a6-8653-4706-a01b-fd4af4ee26d7

Reported adverse events (FAERS/openFDA)#

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