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What is the most important information I should know about acetaminophen/ chlorpheniramine/ pyrilamine/ phenylephrine/ phenylpropanolamine?

Use caution when driving, operating machinery, or performing other hazardous activities. Acetaminophen/chlorpheniramine/pyrilamine/phenylephrine/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 you are taking acetaminophen/chlorpheniramine/pyrilamine/phenylephrine/phenylpropanolamine. Alcohol may also cause damage to your liver when taken with acetaminophen.

What is acetaminophen/ chlorpheniramine/ pyrilamine/ phenylephrine/ 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.

Chlorpheniramine and pyrilamine are antihistamines. They work against the naturally occurring chemical histamine in the body. Chlorpheniramine and pyrilamine prevent sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Phenylephrine and phenylpropanolamine are decongestants. They constrict blood vessels (veins and arteries). This reduces the blood flow to certain areas allowing nasal and respiratory (breathing) passages to open up.

Acetaminophen/chlorpheniramine/pyrilamine/phenylephrine/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.

Acetaminophen/chlorpheniramine/pyrilamine/phenylephrine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

Who should not take acetaminophen/ chlorpheniramine/ pyrilamine/ phenylephrine/ 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 this medication if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A serious drug interaction could occur, leading to side effects.

Before taking this medication, tell your doctor if you have

• 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 acetaminophen/chlorpheniramine/pyrilamine/phenylephrine/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/chlorpheniramine/pyrilamine/phenylephrine/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 infant. 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/chlorpheniramine/pyrilamine/phenylephrine/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.