NyQuil Severe + Vicks VapoCOOL Cold and Flu Nighttime

Acetaminophen is a medicine that helps relieve pain and reduce fever.

Dextromethorphan is a medicine that helps suppress coughing. It works on the brain to stop the cough reflex that causes you to cough.

Doxylamine is an antihistamine that helps lessen the effects of histamine, a natural chemical in the body. Histamine can cause symptoms like sneezing, itching, watery eyes, and a runny nose.

Phenylephrine is a decongestant that narrows blood vessels in the nasal passages. When blood vessels are enlarged, it can lead to nasal congestion (a stuffy nose).

NyQuil Severe + Vicks VapoCOOL Cold and Flu Nighttime is a combination medicine used to treat headache, fever, body aches, cough, runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.

NyQuil Severe + Vicks VapoCOOL Cold and Flu Nighttime will not treat a cough that is caused by smoking, asthma, or emphysema.

NyQuil Severe + Vicks VapoCOOL Cold and Flu Nighttime may also be used for other purposes not listed in this medication guide.

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.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

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

Drop the effervescent tablets into a glass of water (at least 4 ounces, or one-half cup). 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.

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

Do not take more of this medication than is recommended. Taking too much acetaminophen can harm your liver or cause death. Call your doctor immediately 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.

You should not use this medicine if you are allergic to acetaminophen, dextromethorphan, 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, methylene blue injection, 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;
• heart disease, coronary artery disease;
• blockage in your digestive tract (stomach or intestines);
• bladder obstruction or other urination problems;
• glaucoma;
• pheochromocytoma (tumor of the adrenal gland);
• overactive thyroid; or
• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known whether this medication will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

NyQuil Severe + Vicks VapoCOOL Cold and Flu Nighttime 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 a doctor's advice if you are breast-feeding a baby.

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 happen even if you have taken acetaminophen before without any 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 take any medicine that contains acetaminophen again.

This medicine may cause serious side effects. Stop using this medicine and call your doctor immediately if you have:

• pounding heartbeats or fluttering in your chest;
• a light-headed feeling, as if you might pass out;
• anxiety, hallucinations, feelings of fear;
• little or no urinating;
• pale skin, unusual weakness;
• nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or
• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats, seizure).

Common side effects of NyQuil Severe + Vicks VapoCOOL Cold and Flu Nighttime may include:

• drowsiness;
• constipation, diarrhea, upset stomach, vomiting; or
• feeling restless or excited.

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 the FDA at 1-800-FDA-1088.

Since NyQuil Severe + Vicks VapoCOOL Cold and Flu Nighttime is taken as needed, you may not have a set dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not take extra medicine to make up for the missed dose.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Taking too much acetaminophen can be deadly.

The first signs of an acetaminophen overdose include not wanting to eat, feeling sick to your stomach, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Talk to a doctor or pharmacist before using any other cold, allergy, pain, or sleep medicine. Acetaminophen (sometimes called APAP) is found in many combination medicines. Taking certain products together can lead to taking too much acetaminophen, which can result in a fatal overdose. Check the label to see if a medicine has acetaminophen or APAP.

Do not drink alcohol. It may raise your risk of liver damage while taking acetaminophen and can increase certain side effects of doxylamine.

This medicine may cause blurred vision or affect your thinking or reactions. Be cautious if you drive or do anything that needs you to be alert and see clearly.

Ask a doctor or pharmacist before using this medicine if you are taking any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are included in this medication guide.

Taking this medicine with other drugs that cause sleepiness or slow your breathing can make these effects worse. Ask your doctor before taking NyQuil Severe + Vicks VapoCOOL Cold and Flu Nighttime with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.