acetaminophen and phenyltoloxamine

What is the most important information I should know about acetaminophen and phenyltoloxamine?

Do not use acetaminophen and phenyltoloxamine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver or kidney disease, diabetes, glaucoma, urination problems, an enlarged prostate, heart disease, high blood pressure, a stomach ulcer, or an overactive thyroid.

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

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.

What is acetaminophen and phenyltoloxamine?

Acetaminophen is a pain reliever and a fever reducer.

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

Acetaminophen and phenyltoloxamine is used to treat runny nose, sneezing, and pain or fever caused by the common cold, flu, or seasonal allergies.

Acetaminophen and phenyltoloxamine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking acetaminophen and phenyltoloxamine?

You should not take this medication if you are allergic to acetaminophen or phenyltoloxamine.

Do not use acetaminophen and phenyltoloxamine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

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

• liver or kidney disease;
• diabetes;
• glaucoma;
• urination problems;
• an enlarged prostate;
• heart disease or high blood pressure;
• a stomach ulcer; or
• an overactive thyroid.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.

It is not known whether acetaminophen and phenyltoloxamine is harmful to an unborn baby. Do not take this medication without telling your doctor if you are pregnant.

Acetaminophen and phenyltoloxamine can pass into breast milk and may harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

How should I take acetaminophen and phenyltoloxamine?

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.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

An overdose of acetaminophen can damage your liver. Adults should not take more than 1 gram (1000 mg) of acetaminophen per dose or 4 grams (4000 mg) per day. Ask a doctor before taking acetaminophen if you drink more than 3 alcoholic beverages per day, and never take more than 2 grams (2000 mg) of acetaminophen per day.

One tablet of this medicine may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Call your doctor if your symptoms do not improve, or if you have a fever for longer than 3 days.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using acetaminophen and phenyltoloxamine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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?

Seek emergency medical attention or call the Poison Help line at 1 800 222 1222. An overdose of acetaminophen can be fatal.

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.

Overdose symptoms may also include dizziness, drowsiness, diarrhea, and seizure (convulsions).

What should I avoid while taking acetaminophen and phenyltoloxamine?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) and antihistamines are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains acetaminophen, APAP, or an antihistamine.

What are the possible side effects of acetaminophen and phenyltoloxamine?

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.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• fast, pounding, or uneven heartbeat;
• nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay colored stools, jaundice (yellowing of the skin or eyes); or
• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms.

Less serious side effects may include:

• dryness of your eyes, nose, and mouth;
• drowsiness or dizziness;
• blurred vision;
• urinating less than usual; 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 acetaminophen and phenyltoloxamine?

Before using this medicine, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by phenyltoloxamine.

There may be other drugs that can interact with acetaminophen and phenyltoloxamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about acetaminophen and phenyltoloxamine.

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