DrugindexOnline^{2nd edition}

Generic Name: aspirin/chlorpheniramine/dextromethorphan/ phenylpropanolamine (AS pir in/klor fen IR a meen/dex troe meth OR fan/fen ill proe pa NOLE a meen)
Brand Names: Alka Seltzer Plus Cold and Cough

What is aspirin/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

Aspirin is in a class of drugs called salicylates. Aspirin is a pain reliever, an anti-inflammatory, 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 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). This reduces blood flow to affected areas and allows nasal passages to open up.

The combination, aspirin/chlorpheniramine/ dextromethorphan/phenylpropanolamine is used to treat nasal congestion; sinusitis (inflammation of the sinuses); headache; fever; and aches, pains, 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.

Aspirin/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 aspirin/ 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.

Use caution when driving, operating machinery, or performing other hazardous activities. Aspirin/chlorpheniramine/dextromethorphan/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 aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine. Alcohol can also be damaging to the stomach when it is taken with aspirin.

Do not take more of this medication than is recommended. If your symptoms do not improve or if they worsen, see your doctor.

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

Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day. Combined with alcohol, aspirin can be damaging to the stomach.

Do not take aspirin/chlorpheniramine/dextromethorphan/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

• an ulcer,

• a bleeding or blood clotting disorder,

• 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 aspirin/chlorpheniramine/dextromethorphan/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 aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine will harm an unborn baby. Do not take aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine without first talking to your doctor if you are pregnant. This medication passes into breast milk and can harm a nursing baby. 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 aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine. You may require a lower dose of this medication. Do not use any medication that contains aspirin to treat a child or teenager who has a fever, flu symptoms, or chicken pox without first talking to a doctor. In children younger than 20 years of age, aspirin may increase the risk of Reye's syndrome, a rare but often fatal condition.

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

Take aspirin/chlorpheniramine/dextromethorphan/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. Take this medication with food or milk if stomach upset occurs. Do not take more of this medication than is recommended.

Do not take aspirin/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.

Do not take any aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine that smells strongly of vinegar. This smell means that the aspirin has begun to break down.

Store aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine at room temperature away from moisture and heat.

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?

Seek emergency medical attention.

Symptoms of an aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, ringing in the ears, dizziness, hallucinations, seizures, rapid breathing, nausea, and vomiting.

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

Use caution when driving, operating machinery, or performing other hazardous activities. Aspirin/chlorpheniramine/dextromethorphan/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 aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine. Also, alcohol can also be damaging to the stomach when it is taken with aspirin.

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

Avoid prolonged exposure to sunlight. Aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine may increase the sensitivity of the skin to sunlight. Use a sun screen and wear protective clothing when sun exposure is unavoidable.

Be aware of the aspirin content of other over-the-counter and prescription products. Any aspirin content in these products counts toward your total daily dose.

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

If you experience any of the following serious side effects, stop taking aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine and seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• black, bloody, or tarry stools;

• blood in vomit or urine;

• nausea, vomiting, or abdominal pain;

• uncontrolled fever;

• seizures;

• an irregular heartbeat; or

• abnormal behavior, hallucinations, or paranoia.

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

• dryness of the eyes, nose, and mouth;

• drowsiness, lightheadedness, dizziness, or weakness;

• headache;

• faint ringing in the ears;

• upset stomach or indigestion;

• blurred vision;

• restlessness, tremor, insomnia, or anxiety;

• sweating;

• 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 aspirin/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

Do not take aspirin/chlorpheniramine/dextromethorphan/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.

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

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

Drugs other than those listed here may also interact with aspirin/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 aspirin/chlorpheniramine/ dextromethorphan/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Aspirin/chlorpheniramine/dextromethorphan/phenylpropanolamine is available over the counter under the brand name Alka-Seltzer Plus Cough and Cold 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.

• 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.

Copyright 1996-2006 Cerner Multum, Inc. Version: 5.01. Revision Date: 8/10/04 3:11:44 PM.