Acetaminophen, doxylamine, and phenylephrine

Name: Acetaminophen, doxylamine, and phenylephrine

What is acetaminophen, doxylamine, and phenylephrine?

Acetaminophen is a pain reliever and fever reducer.

Doxylamine 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, doxylamine, and phenylephrine is a combination medicine used to treat headache, sinus pain, runny nose, sneezing, and sinus congestion caused by allergies, the common cold, or the flu.

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

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

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.

Acetaminophen 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.

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

You should not use this medication if you are allergic to acetaminophen, doxylamine, 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:

  • asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

  • a blockage in your stomach or intestines;

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

  • kidney disease;

  • high blood pressure, heart disease, coronary artery disease, or recent heart attack;

  • enlarged prostate or urination problems;

  • glaucoma;

  • diabetes;

  • epilepsy or other seizure disorder;

  • pheochromocytoma (an adrenal gland tumor);

  • overactive thyroid; or

  • if you take a blood thinner (warfarin, Coumadin).

It is not known whether acetaminophen, doxylamine, and phenylephrine will harm an unborn baby. Do not use this medicine without your doctor's advice if you are pregnant.

This medication may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without your doctor's advice if you are breast-feeding a baby.

Acetaminophen, doxylamine, and phenylephrine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no 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. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using this medicine and call your doctor at once if you have:

  • chest pain, rapid pulse, fast or uneven heart rate;

  • confusion, hallucinations, severe nervousness, tremor, seizure (convulsions);

  • easy bruising or bleeding, unusual weakness;

  • little or no urinating;

  • liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety.

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

Common side effects may include:

  • dizziness, drowsiness;

  • mild headache, blurred vision;

  • dry mouth, nose, or throat;

  • constipation;

  • feeling restless or excited (especially in children); or

  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

(web3)