Daytime Nighttime Cold and Flu Relief

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It works on the brain to stop the cough reflex that causes coughing.

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

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

Daytime Nighttime Cold and Flu Relief 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.

Daytime Nighttime Cold and Flu Relief will not treat a cough caused by smoking, asthma, or emphysema.

Daytime Nighttime Cold and Flu Relief may also be used for other purposes not listed in this medication guide.

Use exactly as directed on the label, or as your doctor prescribes. 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. Taking too much acetaminophen can harm your liver or lead to 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. Misusing cough and cold medicines in very young children can result in death.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the tablet may release too much of the drug at once.

Measure liquid medicine using 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 it all right away.

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

If you need surgery or medical tests, inform the surgeon or doctor in advance if you have taken this medicine in the past few days.

Store at room temperature away from moisture and heat. Do not let liquid medicine 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, methylene blue injection, 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.

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.

Daytime Nighttime Cold and Flu Relief 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 faint;
• 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, ringing in your ears, chest pain, shortness of breath, uneven heartbeats, seizure).

Common side effects of Daytime Nighttime Cold and Flu Relief 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 Daytime Nighttime Cold and Flu Relief 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 almost 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, throwing up, stomach pain, sweating, and feeling confused or weak. Later signs may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes called APAP) is found 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.

Do not drink alcohol. It may raise your risk of liver damage while you are taking acetaminophen and can increase some 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 able to see well.

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.

Using this medicine with other drugs that cause drowsiness or slow your breathing can make these effects worse. Ask your doctor before taking Daytime Nighttime Cold and Flu Relief with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.