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What is the most important information I should know about acetaminophen, diphenhydramine, and phenylephrine?

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

Do not take acetaminophen, diphenhydramine, and phenylephrine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.

Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.

What is acetaminophen, diphenhydramine, and phenylephrine?

Acetaminophen is a pain reliever and a fever reducer. It is used to treat many conditions, including headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

Diphenhydramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Diphenhydramine 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, diphenhydramine, and 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, diphenhydramine, and phenylephrine may also be used for purposes other than those listed in this medication guide.

Who should not take acetaminophen, diphenhydramine, 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, diphenhydramine, and 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 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, diphenhydramine, and 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, diphenhydramine, and phenylephrine will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. Acetaminophen, diphenhydramine, and phenylephrine can pass into breast milk and may affect a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. 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. If you are over 60 years of age, you may be more likely to experience side effects from acetaminophen, diphenhydramine, and phenylephrine. You may need a lower dose of the medication.