Ornex

Acetaminophen is used to relieve pain and reduce fever.

Pseudoephedrine is a decongestant that works by shrinking blood vessels in the nasal passages. When blood vessels are swollen, it can lead to nasal congestion (stuffy nose).

Ornex is a combination medicine that treats headache, fever, body aches, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Ornex may also be used for other purposes not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

The chewable tablet must be chewed before you swallow it.

Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat.

Ask a doctor before taking medicine that contains acetaminophen if you have ever had liver disease, or if you drink more than 3 alcoholic beverages per day.

You should not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Do not use cold medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Ask a doctor before taking any medicine that contains acetaminophen if you have ever had liver disease, or if you drink more than 3 alcoholic beverages each day.

You should not use Ornex if you are allergic to acetaminophen (Tylenol) or pseudoephedrine, or if you have untreated or uncontrolled conditions such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid.

Do not use cough or cold medicine if you have taken an MAO inhibitor in the last 14 days. A dangerous drug interaction could happen. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Ask a doctor or pharmacist if it is safe for you to take Ornex if you have:

• liver disease, cirrhosis, or a history of alcoholism;
• diabetes;
• epilepsy or another seizure disorder;
• pheochromocytoma (an adrenal gland tumor); or
• an enlarged prostate or urination problems.

It is not known if Ornex will harm an unborn baby. Do not use cough or cold medicine without a doctor's advice if you are pregnant.

Acetaminophen and pseudoephedrine may pass into breast milk and could harm a nursing baby. Decongestants might also reduce breast milk production. Do not use cough or cold medicine without a doctor's advice if you are breastfeeding.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This can happen even if you have taken acetaminophen before without any issues. Stop taking Ornex and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never take any medicine that contains acetaminophen again.

The medicine may cause serious side effects. Stop using the medicine and call your doctor immediately if you experience:

• fast, slow, or uneven heart rate;
• confusion, hallucinations;
• tremor, seizure (convulsions);
• little or no urinating;
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, seizure).

Common side effects of Ornex may include:

• dizziness, weakness;
• mild headache;
• mild nausea, diarrhea, upset stomach;
• runny nose;
• feeling nervous, restless, or anxious; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Since Ornex is taken as needed, you might not have a regular dosing schedule. If you are taking the medication regularly and miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not take extra medicine to compensate for the missed dose.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Taking too much acetaminophen can be deadly.

The first signs of an acetaminophen overdose include not wanting to eat, feeling sick to your stomach, throwing up, stomach pain, sweating, and feeling confused or weak. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

This medication may affect your thinking or reactions. Be cautious if you drive or do anything that requires you to stay alert.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medicine. Acetaminophen (sometimes called APAP) is found in many combination medicines. Taking certain products together can lead to getting too much acetaminophen, which can result in a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Other drugs may interact with acetaminophen and pseudoephedrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform each of your health care providers about all medicines you are currently using and any medicine you begin or stop using.