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

Use caution when driving, operating machinery, or performing other hazardous activities. Acetaminophen/chlorpheniramine/phenylephrine 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/chlorpheniramine/phenylephrine. Alcohol and acetaminophen together may also be damaging to the liver.

What is acetaminophen/chlorpheniramine/phenylephrine?

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 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.

Phenylephrine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas, which decreases swelling and allows nasal and respiratory (breathing) passages to open up.

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

What should I discuss with my healthcare provider before taking acetaminophen, chlorpheniramine, and phenylephrine?

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. Do not take acetaminophen/chlorpheniramine/phenylephrine 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

• kidney disease,
• liver disease,

• diabetes,

• glaucoma,

• 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/phenylephrine, 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/phenylephrine will be harmful to an unborn baby. Do not take acetaminophen/chlorpheniramine/phenylephrine without first talking to your doctor if you are pregnant or could become pregnant during treatment. This medication can pass into breast milk and may be harmful to 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/chlorpheniramine/phenylephrine. You may need a lower dose of the medication. 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.