Norel® Ad

Norel® Ad
SPL v14
SPL
SPL Set ID 53d9ed3c-212d-4b12-ac35-8bd49382b49d
Route
ORAL
Published
Effective Date 2022-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Chlorpheniramine (4 mg) Phenylephrine (10 mg)
Inactive Ingredients
Silicon Dioxide Crospovidone, Unspecified Magnesium Stearate Microcrystalline Cellulose Povidone K30 Starch, Corn Stearic Acid D&c Yellow No. 10 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: 0425;US Shape: triangle Color: yellow Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-04-27

Description

Acetaminophen 325 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg

Purpose

Pain reliever Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Description

Acetaminophen 325 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg

Uses

Temporarily relieves these symptoms due to the common cold or flu

  • nasal congestion
  • runny nose
  • minor aches and pains
  • headache
  • sore throat
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • sinus congestion and pressure
  • temporarily reduces fever
Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 6 tablets in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Allergy alert:Acetaminophen may cause severe skin reaction.

Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, speak with a healthcare provider.

Directions
  • do not take more than directed (see overdose warning)
  • adults and children 12 years of age and over: take 1 tablet every 4 hours, while symptoms persist
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years of age: ask a doctor
Do Not Use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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
Other Information

store at 20°-25°C (68°-77°F)

Overdose Warning:Keep this and all medication out of the reach of children. In case of accidental overdose, seek medical help or contact a Poison Control Center immediately.

Inactive Ingredients

Colloidal Silicon Dioxide, Crospovidone Polyplasdone, Magnesium Stearate (vegetable base), Microcrystalline Cellulose, Povidone K-30, Pregelatinized Starch, Stearic Acid, D&C Yellow #10, FD&C Yellow #6.

Questions Or Comments

Please visit www.uspco.comor contact us at US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036

Principal Display Panel

Figure 1:Norel ®AD container label

When Using This Product
  • do not exceed recommended dosage
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Stop Use and Ask A Doctor If
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • you get nervous, dizzy, or sleepless
  • new symptoms occur
If Pregnant Or Breast Feeding
  • ask a health professional before use
Active Ingredients (per Tablet)

Acetaminophen 325 mg

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

Keep Out of the Reach of Children.

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking any other nasal decongestant or stimulant
  • taking sedatives or tranquilizers

Structured Label Content

Uses

Temporarily relieves these symptoms due to the common cold or flu

  • nasal congestion
  • runny nose
  • minor aches and pains
  • headache
  • sore throat
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • sinus congestion and pressure
  • temporarily reduces fever
Purpose

Pain reliever

Antihistamine

Nasal decongestant

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 6 tablets in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product

Allergy alert:Acetaminophen may cause severe skin reaction.

Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning:If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, speak with a healthcare provider.

Directions
  • do not take more than directed (see overdose warning)
  • adults and children 12 years of age and over: take 1 tablet every 4 hours, while symptoms persist
  • do not take more than 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years of age: ask a doctor
Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • 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
Other Information

store at 20°-25°C (68°-77°F)

Overdose Warning:Keep this and all medication out of the reach of children. In case of accidental overdose, seek medical help or contact a Poison Control Center immediately.

Inactive Ingredients

Colloidal Silicon Dioxide, Crospovidone Polyplasdone, Magnesium Stearate (vegetable base), Microcrystalline Cellulose, Povidone K-30, Pregelatinized Starch, Stearic Acid, D&C Yellow #10, FD&C Yellow #6.

Questions Or Comments (Questions or Comments)

Please visit www.uspco.comor contact us at US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036

Principal Display Panel

Figure 1:Norel ®AD container label

When Using This Product (When using this product)
  • do not exceed recommended dosage
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • you get nervous, dizzy, or sleepless
  • new symptoms occur
If Pregnant Or Breast Feeding (If pregnant or breast feeding)
  • ask a health professional before use
Active Ingredients (per Tablet) (Active Ingredients (per tablet))

Acetaminophen 325 mg

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

Keep Out of the Reach of Children. (Keep out of the reach of children.)

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking any other nasal decongestant or stimulant
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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