Acetaminophen, diphenhydramine, and phenylephrine

Acetaminophen is a pain reliever and fever reducer.

Diphenhydramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Acetaminophen, diphenhydramine, and phenylephrine is a combination medicine used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Acetaminophen, diphenhydramine, and phenylephrine may also be used for purposes not listed in this medication guide.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen, and can increase certain side effects of diphenhydramine.

This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Acetaminophen/diphenhydramine/phenylephrine 325 mg-12.5 mg-5 mg oral tablet:
12 yrs or older: 2 tablets orally every 4 hours not to exceed 12 tablets daily.
6 yrs to 11 yrs: 1 tablet orally every 4 hours not to exceed 5 tablets daily.

Acetaminophen/diphenhydramine/phenylephrine 325 mg-25 mg-5 mg oral tablet:
12 yrs or older: 2 tablets orally every 4 hours not to exceed 12 tablets daily.

Acetaminophen/diphenhydramine/phenylephrine 325 mg-12.5 mg-5 mg/15 mL oral syrup
12 yrs or older: 30 mL orally every 4 hours not to exceed 180 mL daily.

Acetaminophen/diphenhydramine/phenylephrine 650 mg-25 mg-10 mg oral powder for reconstitution (one packet):
12 yrs or older: one packet dissolved in 8 oz hot water orally every 4 hours; sip while hot. Consume entire drink within 10 to 15 minutes. Do not exceed 6 packets in 24 hours.

Acetaminophen/diphenhydramine/phenylephrine 160 mg-6.25 mg-2.5 mg/5 mL oral liquid:
12 yrs or older: 20 mL orally every 4 hours not to exceed 6 doses in any 24 hour period.
Acetaminophen/diphenhydramine/phenylephrine 325 mg-12.5 mg-5 mg/10 mL oral liquid:
12 years or older: 20 mL orally every 4 hours not to exceed 6 doses in any 24 hour period.
6 years to under 12 years of age: 10 mL every 4 hours not to exceed 5 doses in any 24 hour period.
Acetaminophen/diphenhydramine/phenylephrine 650 mg-25 mg-10 mg/20 mL oral liquid:
12 years or older: 20 mL orally every 4 hours not to exceed 6 doses in any 24 hour period.

Data not available

Severe liver damage may occur if taken with other drugs containing acetaminophen.

Store oral liquid at room temperature; do not refrigerate.