What is the most important information I should know about acetaminophen/brompheniramine/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/brompheniramine/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/brompheniramine/phenylpropanolamine. Alcohol may also cause damage to the
liver when taken with
acetaminophen.
What is acetaminophen/brompheniramine/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.
Brompheniramine is an antihistamine. It blocks the effects of the naturally occurring
chemical histamine in the body. Brompheniramine 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 the blood flow to certain areas, which allows nasal passages to open up.
Acetaminophen/brompheniramine/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/brompheniramine/phenylpropanolamine may also be used for purposes
other than those listed in this medication guide.
Who should not take acetaminophen/brompheniramine/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 if you have these conditions.
Do not take acetaminophen/brompheniramine/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
You may not be able to take
acetaminophen/brompheniramine/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 acetaminophen/brompheniramine/phenylpropanolamine will
harm an unborn baby. Do not take acetaminophen/brompheniramine/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 acetaminophen/brompheniramine/phenylpropanolamine.
Read the package label for directions or consult your doctor or
pharmacist before
treating a child with this medication. Children are more susceptible than adults to the effects of
medicines and may have unusual reactions.
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