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#
Contacts and useful links#
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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1046781 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 2 |
| 1046781 | acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 2 |
| 1046781 | APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 2 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CHLORPHENIRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| PHENYLEPHRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50332-0153-4 | Relief-PE | 100 in 1 BOX, UNIT-DOSE | TABLET, COATED | 100 | 2 | |
| 50332-0153-7 | Relief-PE | 250 in 1 BOX, UNIT-DOSE | TABLET, COATED | 250 | 2 |
Products#
Every source-derived product name is available through these pages.
- Relief-PE
- ACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINE
- ACETAMINOPHEN
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- STARCH, CORN
- STEARIC ACID
- CROSPOVIDONE
- MICROCRYSTALLINE CELLULOSE
- HYPROMELLOSES
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50332-0153 | 50332-0153-4, 50332-0153-7 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| CROSPOVIDONE | 2S7830E561 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Relief-PE | ACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINE | HART Health | 9475fb51-931b-4a89-be6b-62e715d0883e | 2026-01-15 | Warnings | 50332-0153-4 50332-0153-7 50332-0153 50332015307 50332015304 129bfe8e-117e-4a42-98eb-e25990b3f2a5 9475fb51-931b-4a89-be6b-62e715d0883e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
