NiteTime Cold and Flu

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

Dextromethorphan is a medicine that helps to suppress coughing. It works on the brain's cough reflex that triggers the urge 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.

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

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

NiteTime Cold and Flu may also be used for other reasons not mentioned 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 NiteTime Cold and Flu 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 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.

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 occur. 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 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 can happen even if you have taken acetaminophen before without any problems. Stop taking this medicine and call your doctor immediately if you notice 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 it and call your doctor right away if you experience:

• severe headache, seizure (convulsions);
• fast, pounding, or uneven 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 NiteTime Cold and Flu 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 may report side effects to FDA at 1-800-FDA-1088.

Since this medicine is used as needed, you may not have a dosing schedule. If you do have a schedule, 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 use 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 early 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 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.

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

This medication can cause blurry vision and may affect your ability to think or react. Be cautious if you drive or do anything that needs you to be alert and see clearly.

Ask a doctor or pharmacist before using NiteTime Cold and Flu if you are also taking any other medications, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medications can cause unwanted or dangerous effects when used together. Not all possible interactions are mentioned 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 NiteTime Cold and Flu with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.