Relief-pe

Relief-pe
SPL v2
SPL
SPL Set ID 9475fb51-931b-4a89-be6b-62e715d0883e
Route
ORAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Phenylephrine (5 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Starch, Corn Stearic Acid Crospovidone Microcrystalline Cellulose Hypromelloses Polyethylene Glycol, Unspecified Povidone

Identifiers & Packaging

Pill Appearance
Imprint: AZ275 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-04-16

Description

Active Ingredients (in each tablet): Acetaminophen 325mg Phenylephrine HCl 5mg Chlorpheniramine Maleate 2mg


Medication Information

Warnings and Precautions

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
Indications and Usage

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

Dosage and Administration

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

Description

Active Ingredients (in each tablet): Acetaminophen 325mg Phenylephrine HCl 5mg Chlorpheniramine Maleate 2mg

Section 34088-5

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.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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

Section 50567-7

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.

Section 50568-5

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
Section 50569-3

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
Section 50570-1

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
Section 51727-6



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

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose:

Pain Reliever/Fever Reducer

Antihistamine

Nasal Decongestant

Section 55106-9

Active Ingredients (in each tablet):

Acetaminophen 325mg

Phenylephrine HCl 5mg

Chlorpheniramine Maleate 2mg


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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
Section 34088-5 (34088-5)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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.

Section 50568-5 (50568-5)

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
Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)



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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose:

Pain Reliever/Fever Reducer

Antihistamine

Nasal Decongestant

Section 55106-9 (55106-9)

Active Ingredients (in each tablet):

Acetaminophen 325mg

Phenylephrine HCl 5mg

Chlorpheniramine Maleate 2mg


Advanced Ingredient Data


Raw Label Data

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