Cold and Flu Nighttime Relief

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

Dextromethorphan is a medicine that helps suppress coughing. It works on the cough reflex in the brain that triggers coughing.

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.

Cold and Flu Nighttime Relief is a combination medicine used to treat headache, fever, body aches, cough, runny nose, sneezing, and sore throat caused by allergies, the common cold, or the flu.

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

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

Use exactly as directed on the label, or as prescribed by your doctor. Do not use for longer than recommended. Cough and cold 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.

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

Stop taking the medicine and call your doctor if you still have a sore throat after 2 days, or if you have a fever, headache, rash, nausea, or vomiting.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken Cold and Flu Nighttime Relief 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 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 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.

Ask a doctor before taking medicine that contains acetaminophen if you have ever had liver disease, or if you drink more than 3 alcoholic beverages per day.

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 furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

You should not use this medication if you are allergic to acetaminophen (Tylenol), doxylamine, or dextromethorphan.

Ask a doctor or pharmacist before taking this medicine if you have any medical condition, 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;
• an enlarged prostate, problems with urination;
• glaucoma; or
• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

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

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

Artificially sweetened liquid medicine may contain phenylalanine. Check the medication label if you have phenylketonuria (PKU).

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.

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

In rare cases, acetaminophen may lead to a severe skin reaction that can be life-threatening. This can happen even if you have taken acetaminophen before without any issues. Stop taking this medicine and contact your doctor immediately if you notice skin redness or a rash that spreads and causes blistering and peeling. If you experience this kind of reaction, you should never take any medicine that contains acetaminophen again.

The medicine may cause serious side effects. Stop using the medicine and call your doctor right away if you experience:

• severe headache, seizure (convulsions);
• fast, pounding, or irregular heartbeats;
• confusion, hallucinations, severe dizziness or drowsiness, slow or shallow breathing;
• tremor, restless muscle movements;
• little or no urinating;
• flu symptoms, easy bruising, unusual bleeding, pale skin, weakness, feeling light-headed; or
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Cold and Flu Nighttime Relief may include:

• headache, sleep problems (insomnia);
• upset stomach, diarrhea or constipation;
• dry eyes, blurred vision, dry mouth or nose;
• mild dizziness or drowsiness, trouble concentrating;
• feeling restless or excited (especially in children); or
• mild skin rash.

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

Since this medicine is taken as needed, you might not have a regular dosing schedule. If you do have a schedule and miss a dose, take it as soon as you remember. If it's almost time for your next scheduled dose, skip the missed dose. Do not use extra medicine to compensate 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 are loss of appetite, nausea, 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.

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

Avoid drinking alcohol. It may raise your risk of liver damage while you are taking acetaminophen and can increase certain side effects.

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

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

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