acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine

What is the most important information I should know about this medicine?

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.

What is acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine?

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the cough reflex in the brain that triggers coughing.

Doxylamine 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, dextromethorphan, doxylamine, and pseudoephedrine is a combination medicine used to treat headache, fever, body aches, cough, runny nose, sneezing, and sinus congestion caused by the common cold, or the flu.

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

What should I discuss with my healthcare provider before taking this medicine?

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, methylene blue injection, 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:

• a cough with mucus;
• liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;
• heart disease, high blood pressure;
• glaucoma;
• diabetes;
• a thyroid disorder;
• enlarged prostate with urination problems; or
• if you take a blood thinner such as warfarin (Coumadin, Jantoven).

How should I take this medicine?

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

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

• your symptoms get worse, or you have new symptoms;
• you still have a fever after 3 days of use;
• you still have a sore throat after 2 days of use;
• you have any redness or swelling; or
• you have a sore throat with fever, skin rash, ongoing headache, nausea, or vomiting.

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.

What happens if I miss a dose?

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.

What happens if I overdose?

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

What should I avoid while taking this medicine?

What are the possible side effects of this medicine?

• pounding heartbeats or fluttering in your chest;
• a light-headed feeling, like you might pass out;
• anxiety, feeling nervous, trouble sleeping;
• little or no urination; or
• liver problems --nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

Common side effects may include:

• drowsiness;
• constipation, diarrhea, upset stomach, vomiting; or
• feeling restless or excited (especially in children).

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 FDA at 1-800-FDA-1088.

What other drugs will affect this medicine?

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine.