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What is the most important information I should know about acetaminophen/ caffeine/ 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. Acetaminophen/caffeine/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 acetaminophen/caffeine/chlorpheniramine/phenylpropanolamine. Alcohol may also cause damage to the liver when taken with acetaminophen.

What is acetaminophen/ caffeine/ chlorpheniramine/ 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.

Caffeine is added to this product to increase the effects of acetaminophen and to decrease the drowsiness caused by chlorpheniramine.

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.

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

Acetaminophen/caffeine/chlorpheniramine/phenylpropanolamine is used to treat nasal congestion; itchy, watery eyes; itchy throat; sneezing; headache; fever; and other symptoms 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/caffeine/chlorpheniramine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.