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What is the most important information I should know about aspirin/chlorpheniramine/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/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/phenylpropanolamine. Alcohol can also be damaging to the stomach when it is taken with aspirin.

Do not take more of this medication than is directed. Consult your doctor if your symptoms are not being relieved.

What is aspirin/chlorpheniramine/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.

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/phenylpropanolamine, is used to treat nasal congestion, sinusitis (inflammation of the sinuses), headache, fever, and aches and pains 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/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

Who should not take aspirin/chlorpheniramine/phenylpropanolamine?

Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day. Alcohol can cause stomach bleeding when it is combined with any medicine that contains aspirin.

Do not take aspirin/chlorpheniramine/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 or a bleeding or coagulation 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/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/phenylpropanolamine 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 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/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.