Acuflex

Use Acuflex as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.

What do I do if I miss a dose?

• If you take this medicine on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times Acuflex is taken on an as needed basis. Do not take more often than told by the doctor.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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.

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

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.

Acuflex may harm an unborn baby. Do not take this medication without telling your doctor if you are pregnant. Acuflex 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.

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.

Do not take more than 1 gram (1000 mg) of acetaminophen per dose or 4 grams (4000 mg) per day. An acetaminophen overdose can damage your liver. Know the amount of acetaminophen in the 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 you to have unusual results with certain medical tests. Tell any doctor who treats you that you are taking Acuflex.

Store Acuflex at room temperature away from moisture and heat.

Seek emergency medical attention if you think you have used too much of this medicine.

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

Applies to acetaminophen / phenyltoloxamine: oral liquid, oral tablet, oral tablet extended release

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:

• Feeling sleepy.
• Dizziness.
• Feeling nervous and excitable.
• Dry mouth.
• Dry nose.
• Upset stomach.

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.