DayQuil Cold and Flu

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

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

Phenylephrine is a medicine that helps relieve nasal congestion by making blood vessels in the nose smaller. When blood vessels are swollen, it can lead to a stuffy nose.

DayQuil Cold and Flu is a combination medicine used to relieve headache, fever, body aches, cough, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

DayQuil Cold and Flu will not help with a cough caused by smoking, asthma, or emphysema.

DayQuil Cold and Flu may also be used for other reasons that are not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use more or less than recommended, or for longer than advised. This medicine is usually taken only for a short time until your symptoms improve.

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

Do not give this medication to a child younger than 4 years old. Always consult a doctor before giving cough or cold medicine to a child. Misuse of cough or cold medicine in very young children can lead to death.

Measure liquid medicine with a special dose measuring spoon or medicine cup, not with a regular tablespoon. 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 immediately.

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 worsen, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, inform the surgeon or doctor beforehand if you have taken this medicine in 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 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.

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.

You should not use this medication if you are allergic to acetaminophen, dextromethorphan, or phenylephrine.

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

• liver disease, alcoholism, or if you drink more than 3 alcoholic beverages per day;
• high blood pressure, heart disease, coronary artery disease;
• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
• diabetes;
• glaucoma;
• overactive thyroid;
• epilepsy or other seizure disorder;
• pheochromocytoma (an adrenal gland tumor); or
• bladder obstruction or other urination problems.

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

Acetaminophen, dextromethorphan, and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

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

In rare situations, acetaminophen can cause a severe skin reaction that might be life-threatening. This can happen even if you have taken acetaminophen before without any issues. Stop using this medicine and contact your doctor immediately if you experience skin redness or a rash that spreads and leads to blistering and peeling. If you have this type of reaction, you should never take any medicine that contains acetaminophen again.

DayQuil Cold and Flu can cause serious side effects. Stop using DayQuil Cold and Flu and contact your doctor right away if you have:

• chest pain, fast, slow, or uneven heart rate;
• severe dizziness, feeling like you might faint;
• mood changes, confusion, hallucinations, seizures (convulsions);
• little or no urination;
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, chest pain, uneven heartbeats, seizures).

Common side effects of DayQuil Cold and Flu may include:

• dizziness, weakness, mild headache;
• diarrhea, upset stomach;
• dry mouth, nose, or throat;
• feeling nervous, restless, irritable, or anxious; or
• trouble sleeping (insomnia).

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

Since DayQuil Cold and Flu is taken as needed, you might not have a set dosing schedule. If you are taking the medicine regularly, take the missed dose as soon as you remember. Skip the missed dose if it is nearly time for your next scheduled 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 feeling confused or weak. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include severe versions of some of the side effects listed in this medication guide.

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

This medication may affect your thinking or reactions. Be cautious if you drive or do anything that requires alertness.

Avoid drinking alcohol. It may increase your risk of liver damage while you are using acetaminophen.

Other drugs may interact with DayQuil Cold and Flu, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform all of your health care providers about all medicines you are currently using and any medicines you begin or stop using.