Acuflex

Acuflex contains a combination of 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.

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

Take Acuflex exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

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

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are taking Acuflex.

Do not use Acuflex if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take Acuflex before the MAO inhibitor has cleared from your body.

Acuflex can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) of acetaminophen per day.

Do not take Acuflex without your doctor's advice if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take acetaminophen.

Before taking Acuflex, tell your doctor if you are allergic to any drugs, or 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.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Acuflex.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

Acetaminophen and phenyltoloxamine may harm 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.

• fast, pounding, or uneven heartbeat;
• nausea, stomach pain, low fever, 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 Acuflex side effects may include:

• dry 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.

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

Overdose symptoms may include dizziness, drowsiness, nausea, vomiting, diarrhea, stomach pain, loss of appetite, increased sweating, seizure (convulsions), or coma.

There may be other drugs that can interact with Acuflex. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.