Acetaminophen and phenylephrine

Name: Acetaminophen and phenylephrine

What is acetaminophen and phenylephrine?

Acetaminophen is a pain reliever and a fever reducer.

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

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

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

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

You should not use this medicine if you are allergic to acetaminophen (Tylenol) or phenylephrine.

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.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

  • liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;

  • high blood pressure, heart disease, coronary artery disease;

  • overactive thyroid;

  • pheochromocytoma (an adrenal gland tumor); or

  • if you take an anti-depressant.

It is not known whether acetaminophen and phenylephrine will harm an unborn baby. Do not use cough or cold medicine without a doctor's advice if you are pregnant.

Acetaminophen and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use cough or cold medicine without a doctor's advice if you are pregnant.

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.

What happens if I miss a dose?

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.

For the Consumer

Applies to acetaminophen / phenylephrine: oral capsule, oral packet, oral tablet

Usual Adult Dose for Headache

Acetaminophen 250 mg - phenylephrine 5 mg oral effervescent tablet:
2 tablets fully dissolved in 4 ounces of water every 4 hours.

Acetaminophen 325 mg - phenylephrine 5 mg oral tablet:
2 tablets orally every 4 hours. Do not take more than 12 tablets in 24 hours.

Acetaminophen 500 mg - phenylephrine 15 mg oral tablet:
2 tablets orally every 6 hours. Do not take more than 8 tablets in 24 hours.

Acetaminophen 500 mg - phenylephrine 5 mg oral tablet:
2 tablets orally every 4 to 6 hours. Do not take more than 8 tablets in 24 hours.

Acetaminophen 650 mg - phenylephrine 10 mg oral powder:
Dissolve 1 packet in 8 ounces of hot water and drink in 10 to 15 minutes. May repeat every 4 hours. Not to exceed 6 packets daily.

Acetaminophen / phenylephrine Pregnancy Warnings

Acetaminophen has not been formally assigned to a pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Phenylephrine has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Acetaminophen-phenylephrine is only recommended for use during pregnancy when benefit outweighs risk.

Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity. Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women compared to nonpregnant women. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women. One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women. That study also suggested that acetaminophen does not affect thromboxane production.

(web3)