acetaminophen/dextromethorphan/guaifenesin/ phenylpropanolamine

	What is the most important information I should know about acetaminophen/ dextromethorphan/ guaifenesin/ phenylpropanolamine?
	What is acetaminophen/ dextromethorphan/ guaifenesin/ phenylpropanolamine?
	Who should not take acetaminophen/ dextromethorphan/ guaifenesin/ phenylpropanolamine?
	How should I take acetaminophen/ dextromethorphan/ guaifenesin/ phenylpropanolamine?
	What happens if I miss a dose?
	What happens if I overdose?
	What should I avoid while taking acetaminophen/ dextromethorphan/ guaifenesin/ phenylpropanolamine?
	What are the possible side effects of acetaminophen/ dextromethorphan/ guaifenesin/ phenylpropanolamine?
	What other drugs will affect acetaminophen/ dextromethorphan/ guaifenesin/ phenylpropanolamine?
	Where can I get more information?
	What does my medication look like?
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Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Use caution when driving, operating machinery, or performing other hazardous activities. Acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine. Alcohol may also cause damage to the liver when it is taken with acetaminophen.

Acetaminophen is a pain reliever and a fever reducer. It is used to treat many conditions, such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

Dextromethorphan is a cough suppressant. It suppresses an area in the brain that causes coughing.

Guaifenesin is an expectorant. It thins mucous, increases the lubrication of the respiratory tract (lungs, nose, and throat), and improves the removal of mucous. It is used to break up congestion and mucous to make breathing easier.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal passages to open up.

Acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine is used to treat nasal and chest congestion, sinusitis (inflammation of the sinuses), headache, body aches, and coughs associated with allergies, hay fever, flu, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

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 a medication that contains acetaminophen.

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

Before taking this medication, tell your doctor if you have

• kidney disease,
• liver disease,
• diabetes,
• glaucoma,
• any type of heart disease or high blood pressure,
• thyroid disease,
• emphysema or chronic bronchitis, or
• difficulty urinating or an enlarged prostate.

You may not be able to take acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine, 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 this medication will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant.

This medication 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/dextromethorphan/guaifenesin/phenylpropanolamine.

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.

Take acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine 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. Increasing the amount of water you drink may also help to loosen congestion.

Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm. 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 damage the liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never take more than 2 grams (2000 mg) per day.

Do not take acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse or if you have a fever, see your doctor.

Store acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine at room temperature away from moisture and heat.

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

Seek emergency medical attention.

Symptoms of an acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine overdose include flushing, sweating, nausea, vomiting, diarrhea, abdominal pain, seizures, confusion, high blood pressure (headache, redness of face, blurred vision), an irregular heartbeat, numbness of your fingers or toes, hyperactivity, and hallucinations.

Use caution when driving, operating machinery, or performing other hazardous activities. Acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine. Alcohol may also cause damage to the liver when it is taken with acetaminophen.

Acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine 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/dextromethorphan/guaifenesin/phenylpropanolamine is taken with any of these medications.

If you experience any of the following rare but serious side effects, stop taking acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine and seek emergency medical attention or notify your doctor immediately:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
• liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, or severe fatigue);
• blood problems (easy or unusual bleeding or bruising); or
• low blood sugar (fatigue, increased hunger or thirst, dizziness, or fainting).

Other, less serious side effects may be more likely to occur. Continue to take acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine and talk to your doctor or try another similar medication if you experience

• tremor, restlessness, or insomnia;
• nausea or vomiting;
• headache, lightheadedness, or dizziness;
• difficulty urinating; or
• dry eyes, mouth, or nose.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Do not take acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous 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 have diabetes and you notice changes in blood glucose levels during treatment with this medication.

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

Acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine 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/dextromethorphan/guaifenesin/phenylpropanolamine is taken with any of these medications.

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

Your pharmacist has additional information about acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine written for health professionals that you may read.

Acetaminophen/dextromethorphan/guaifenesin/phenylpropanolamine is available with a prescription under the brand name Anatuss Tablets. 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.