Relief-PE

Manufacturer
HART Health | Allegiant Health
Effective date
2026-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:33:17

Label at a glance#

ProductRelief-PE
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet):

Acetaminophen 325mg

Phenylephrine HCl 5mg

Chlorpheniramine Maleate 2mg

OTC - PURPOSE SECTION

Purpose:

Pain Reliever/Fever Reducer

Antihistamine

Nasal Decongestant

INDICATIONS & USAGE SECTION

Temporarily relieves nasal congestion, sinus pressure, and minor aches and pains due to:

  • the common cold
  • hay fever
  • upper respiratory allergies
  • headache
  • itchy/watery eyes
  • runny nose
  • muscular aches

Temporarily reduces fever

WARNINGS SECTION

Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4000mg of acetaminophen 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcohol drinks every day while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

OTC - DO NOT USE SECTION

Do not use:

  • with any other drug containing acetaminophen (prescription or non-prescription)
  • 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, or if you do not know if your prescription drug contains an MAOI

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if

  • you are taking sedatives or tranquilizers
  • you are taking the blood thinning drug warfarin
  • you do not know if other drugs you are taking contain acetaminophen

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • heart, liver, or thyroid disease
  • high blood pressure
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

OTC - WHEN USING SECTION

When using this product to not use more than directed. This product may cause excitability or drowsiness. Alcohol, sedatives and tranquilizers may increase the drowsiness effect. Use caution when driving a motor vehicle or operating machinery.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • an allergic reaction occurs, seek medical help right away
  • you get nervous, dizzy or sleepless
  • new symptom occur
  • fever worsens or lasts for more than 3 days
  • pain or nasal congestion gets worse or lasts more than 7 days
  • redness or swelling is present

These could be signs of serious condition

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.

OVERDOSAGE SECTION

Overdose warning:

Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222.

DOSAGE & ADMINISTRATION SECTION

Directions: Do not take more than directed. Adults and children 12 years of age an over:

  • take 1 to 2 tablets every 6 hours while symptoms persist
  • do not take more than 8 tablets in 24 hours unless directed by a doctor

Children under 12 years of age: ask a doctor

INACTIVE INGREDIENT SECTION


corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelantined starch, stearic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ReliefPEv24f.jpgReliefPEv24f.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral TabletPSN2
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD2
1046781APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
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
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50332-0153-4Relief-PE100 in 1 BOX, UNIT-DOSETABLET, COATED1002
50332-0153-7Relief-PE250 in 1 BOX, UNIT-DOSETABLET, COATED2502

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
50332-015350332-0153-4, 50332-0153-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
Relief-PEACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINEHART Health9475fb51-931b-4a89-be6b-62e715d0883e2026-01-15WarningsExact identifier
ndc (package): 50332-0153-4
ndc (package): 50332-0153-7
ndc (product): 50332-0153
ndc11 (package): 50332015307
ndc11 (package): 50332015304
spl id: 129bfe8e-117e-4a42-98eb-e25990b3f2a5
spl set id: 9475fb51-931b-4a89-be6b-62e715d0883e

Reported adverse events (FAERS/openFDA)#

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