FDA.reportPublic FDA data

Decongestant PE

Manufacturer
Allegiant Health
Effective date
2021-06-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:42:53

Label at a glance#

ProductDecongestant PE Non Drowsy
Active ingredientPHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

Adults and children 12 years and over: 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

store at room temperature 20°– 25°C (68°– 77°F)

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 5mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Use(s)

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

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

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

Pregnancy/Breastfeeding

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: 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

  • do not use if imprinted safety seal under cap is broken or missing

Storage

STORAGE AND HANDLING SECTION

  • store at room temperature 20°– 25°C (68°– 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, lactose, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake,

hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, titanium dioxide.

May contain propylene glycol

Questions

OTC - QUESTIONS SECTION

Call 1-888-952-0050 Monday through Friday

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Decongestant PE
Decongestant PE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1299145phenylephrine HCl 5 MG Oral TabletPSN6
1299145phenylephrine hydrochloride 5 MG Oral TabletSCD6
1299145phenylephrine HCl 5 MG Oral TabletSY6

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128X002X28PND271---phenylephrine-hcl-5mg-1.jpg

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
69168-271-17Decongestant PENon Drowsy300 in 1 BOTTLETABLET3006

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
69168-27169168-271-17

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 HYDROCHLORIDE04JA59TNSJACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PROPYLENE GLYCOL6DC9Q167V3CNTM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52021-06-16full-release2026-06-01 00:01:57

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
Decongestant PE Non DrowsyPHENYLEPHRINE HCLAllegiant Health7a3098b4-381c-4f32-97a7-87b53fd644282021-06-16WarningsExact identifier
ndc (package): 69168-271-17
ndc (product): 69168-271
ndc11 (package): 69168027117
spl id: 2b621db5-4138-44f0-9c86-28468ba954af
spl set id: 7a3098b4-381c-4f32-97a7-87b53fd64428

Reported adverse events (FAERS/openFDA)#

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