What is the most important information I should know about acetaminophen/ dextromethorphan/ guaifenesin/ 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/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.
What is acetaminophen/ dextromethorphan/ guaifenesin/ 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.
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.
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