Acetaminophen, chlorpheniramine, and pseudoephedrine

Acetaminophen is a pain reliever and fever reducer.

Chlorpheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Acetaminophen, chlorpheniramine, and pseudoephedrine is a combination medicine used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Acetaminophen, chlorpheniramine, and pseudoephedrine may also be used for purposes not listed in this medication guide.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

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.

You should not use this medication if you are allergic to acetaminophen, chlorpheniramine, or pseudoephedrine.

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

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

• a blockage in your stomach or intestines;

• liver disease, alcoholism, or if you drink more than 3 alcoholic beverages per day;

• kidney disease;

• high blood pressure, heart disease, coronary artery disease, or recent heart attack;

• enlarged prostate or urination problems;

• glaucoma;

• diabetes;

• epilepsy or other seizure disorder;

• pheochromocytoma (an adrenal gland tumor); or

• overactive thyroid.

It is not known whether acetaminophen, chlorpheniramine, and pseudoephedrine will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant.

This medication may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without your doctor's advice if you are breast-feeding a baby.

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of acetaminophen / chlorpheniramine / pseudoephedrine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.