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Generic Name: acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine (a seet a MIN oh fen/klor fen IR a meen/dex troe meth OR fan/fen ill proe pa NOLE a meen)
Brand Names: Comtrex Cold and Flu Maximum Strength, Comtrex Maximum Strength Cold Relief, Contac Severe Cold and Flu Maximum Stength

What is acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

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.

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

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

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries) allowing nasal passages to open up.

Acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine is used to treat nasal congestion, sinusitis (inflammation of the sinuses), runny nose, watery eyes, headache, body aches, and coughs associated with allergies, hay fever, 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/chlorpheniramine/dextromethorphan/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

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.

Who should not take acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

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.

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/chlorpheniramine/dextromethorphan/phenylpropanolamine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

How should I take acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

Take acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Do not take acetaminophen/chlorpheniramine/dextromethorphan/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.

What happens if I miss a dose?

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.

What happens if I overdose?

Symptoms of an acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, sweating, nausea, vomiting, diarrhea, abdominal pain, seizures, confusion, an irregular heartbeat, hyperactivity, or hallucinations.

What should I avoid while taking acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

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

What are the possible side effects of acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

• 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/chlorpheniramine/dextromethorphan/phenylpropanolamine and talk to your doctor or try another similar medication if you experience

• dryness of the eyes, nose, and mouth;

• drowsiness or dizziness;

• blurred vision;

• difficulty urinating; or

• excitation in children.

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.

What other drugs will affect acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

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 treatment.

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

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

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

Where can I get more information?

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

What does my medication look like?

Acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine is available over the counter under the brand name Comtrex. 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.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.