Norel Ad

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or flu. These symptoms include nasal congestion, runny nose, minor aches and pains, headache, sore throat, sneezing, itchy and watery eyes, itching of the nose or throat, and sinus congestion and pressure. Additionally, this drug temporarily reduces fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years of age and over are advised to take 1 tablet every 4 hours as needed while symptoms persist. It is important not to exceed a total of 6 tablets within a 24-hour period unless directed by a healthcare professional.

For children under 12 years of age, consultation with a doctor is recommended prior to administration.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of the MAOI. This is due to the potential for serious interactions. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should be aware of the following critical warnings regarding liver safety:

Liver Warning

• Adults should not exceed 6 tablets in a 24-hour period, as this is the maximum daily dosage.

• Children should not take more than 5 doses within 24 hours.

• Caution is advised when this product is taken concurrently with other medications containing acetaminophen.

• Patients who consume 3 or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. If any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider.

In the event of an overdose, it is crucial to obtain emergency medical help or contact the Poison Control Center without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Patients should be advised to stop taking the product and contact their healthcare provider if any of the following occur:

• Pain or nasal congestion worsens or lasts longer than 7 days.

• Fever worsens or persists for more than 3 days.

• Redness or swelling is observed.

• New symptoms arise, or the patient experiences nervousness, dizziness, or sleeplessness.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if an adult consumes more than 6 tablets within a 24-hour period, if a child takes more than 5 doses in 24 hours, if the product is used concurrently with other medications containing acetaminophen, or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of such a reaction, it is imperative to discontinue use and seek immediate medical assistance. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare provider.

Common adverse reactions may include worsening pain or nasal congestion lasting more than 7 days, fever that worsens or persists for more than 3 days, and the presence of redness or swelling. Patients should also seek medical advice if they experience nervousness, dizziness, sleeplessness, or the emergence of new symptoms.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, or those experiencing urinary difficulties due to an enlarged prostate gland should consult a healthcare provider prior to use. Furthermore, individuals taking blood thinners such as warfarin, other nasal decongestants or stimulants, or sedatives and tranquilizers should also seek guidance from a healthcare professional or pharmacist before using this product.

Drug Interactions

Acetaminophen has been identified to potentially increase the risk of bleeding when co-administered with warfarin. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients receiving this combination to ensure safe therapeutic levels and to mitigate the risk of adverse effects.

No additional drug interactions or laboratory test interactions have been reported.

Packaging & NDC

Below are the non-prescription pack sizes of Norel Ad (acetaminophen, chlorpheniramine maleate, and phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosing is 1 tablet every 4 hours as needed, with a maximum of 6 tablets in a 24-hour period unless otherwise directed by a physician.

Caution is advised regarding liver health; pediatric patients who exceed 5 doses within 24 hours may be at risk for liver complications. Additionally, excitability may occur, particularly in children. It is essential to keep this medication out of the reach of children, as exceeding the recommended dosage can lead to serious health issues. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is crucial for both children and adults, even if no symptoms are apparent.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if the following conditions are met:

• An adult consumes more than 6 tablets within a 24-hour period, which is the maximum daily dosage.

• A child takes more than 5 doses in a 24-hour period.

• The product is taken concurrently with other medications that contain acetaminophen.

• An adult consumes 3 or more alcoholic drinks daily while using this product.

Due to the potential for increased risk of liver damage, it is recommended that patients with compromised liver function adhere strictly to the prescribed dosage and avoid the use of additional acetaminophen-containing products. Regular monitoring of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Risk of Severe Liver Damage Severe liver damage is a critical concern in instances of overdosage. For adults, the threshold for potential liver injury is exceeded when more than 6 tablets are ingested within a 24-hour period, which is the maximum daily dosage. In pediatric patients, the risk similarly escalates if a child consumes more than 5 doses in the same timeframe.

Additionally, the concomitant use of this product with other medications containing acetaminophen can exacerbate the risk of severe liver damage. Healthcare professionals should be vigilant in assessing a patient's medication history to prevent such interactions.

Furthermore, individuals who consume 3 or more alcoholic beverages daily while using this product are at an increased risk for severe liver damage. It is essential for healthcare providers to counsel patients regarding the dangers of alcohol consumption during treatment.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should initiate appropriate management procedures, which may include monitoring liver function tests and providing supportive care as necessary. Prompt intervention is crucial to mitigate the risk of severe hepatic injury.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion. It is important to emphasize that taking more than the recommended dose can lead to serious health problems. In the event of an overdose, patients should seek medical help or contact the Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

Patients should be instructed not to exceed the recommended dosage. They should be made aware that drowsiness may occur and that they should avoid consuming alcoholic beverages, as alcohol, sedatives, and tranquilizers can enhance drowsiness. Caution should be advised when driving a motor vehicle or operating machinery due to the potential for impaired alertness.

Healthcare providers should inform patients that excitability may occur, particularly in children. It is essential to recommend that patients consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, glaucoma, difficulty urinating due to an enlarged prostate gland, or a breathing problem such as emphysema or chronic bronchitis.

Additionally, patients should be encouraged to ask a doctor or pharmacist before use if they are currently taking the blood-thinning medication warfarin, any other nasal decongestant or stimulant, or sedatives or tranquilizers. This will help ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature of 20°-25°C (68°-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature range to prevent degradation.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Norel Ad, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)