Acetaminophen is a pain reliever and a fever reducer.

Phenyltoloxamine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Phenyltoloxamine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Acetaminophen and phenyltoloxamine is used to treat aches and pains, headache, fever, and congestion associated with the flu, colds, allergies, and hay fever.

Acetaminophen and phenyltoloxamine may also be used for purposes other than those listed in this medication guide.

Take acetaminophen an phenyltoloxamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Never take more acetaminophen and phenyltoloxamine than is directed. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and phenyltoloxamine and never take more than 2 grams (2000 mg) per day.

Consult your doctor if your symptoms do not improve within 10 days (or 5 days for children under 12 years of age) or if they get worse. Do not use this product to treat a fever for more than 3 days.

Store acetaminophen and phenyltoloxamine at room temperature away from moisture and heat.

Do not take acetaminophen and phenyltoloxamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very serious drug interaction could occur, leading to serious side effects.

Urine glucose tests may produce false results while you are taking acetaminophen. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during therapy with acetaminophen and phenyltoloxamine.

Do not take other over-the-counter cough, cold, allergy, diet, pain or sleep medicines while taking acetaminophen and phenyltoloxamine without first talking to your doctor. Other medications may also contain acetaminophen, phenyltoloxamine, or other similar drugs and you may accidentally take too much of these medicines.

Acetaminophen and phenyltoloxamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen and phenyltoloxamine is taken with any of these medications.

Drugs other than those listed here may also interact with acetaminophen and phenyltoloxamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Use caution when driving, operating machinery, or performing other hazardous activities. Acetaminophen and phenyltoloxamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking acetaminophen and phenyltoloxamine. Alcohol may also cause damage to your liver when taken with acetaminophen.

Acetaminophen and phenyltoloxamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen and phenyltoloxamine is taken with any of these medications.

Seek emergency medical attention.

Symptoms of an acetaminophen and phenyltoloxamine overdose may include nausea, vomiting, diarrhea, abdominal pain, sweating, seizures, confusion, sedation, insomnia, tremor, hallucinations, and an irregular heartbeat.

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.

Use caution when driving, operating machinery, or performing other hazardous activities. Acetaminophen and phenyltoloxamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking acetaminophen and phenyltoloxamine. Alcohol may also cause damage to your liver when taken with acetaminophen.

Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease. You may not be able to take acetaminophen.

Do not take acetaminophen and phenyltoloxamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very serious drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• liver disease;

• kidney disease;

• diabetes;

• glaucoma;

• difficulty urinating because of an enlarged prostate, a constricted bladder neck, or any other reason;

• a stenosing peptic (stomach) ulcer;

• high blood pressure or any type of heart disease; or

• an overactive thyroid.

You may not be able to take acetaminophen and phenyltoloxamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

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

Acetaminophen and phenyltoloxamine passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

If you are over 60 years of age, you may be more likely to experience side effects from acetaminophen and phenyltoloxamine.

Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

Your pharmacist has additional information about acetaminophen and phenyltoloxamine written for health professionals that you may read.

Acetaminophen and phenyltoloxamine is available over the counter under the brand names Percogesic, Phenylgesic, Major-gesic, and Acta-Gesic. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.