Cough and Sore Throat Nighttime

Acetaminophen is used to relieve pain and reduce fever.

Dextromethorphan is used to suppress cough. It works on the cough reflex in the brain 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.

Cough and Sore Throat Nighttime is a combination medicine that helps treat headache, fever, body aches, cough, runny nose, sneezing, and sore throat from allergies, the common cold, or the flu.

Cough and Sore Throat Nighttime will not help with a cough caused by smoking, asthma, or emphysema.

Cough and Sore Throat Nighttime may also be used for other reasons not mentioned in this medication guide.

Use exactly as directed on the label, or as your doctor prescribed. Do not use for longer than recommended. Cough and cold medicine is usually taken only for a short time until your symptoms get better.

Do not take more of this medication than is recommended. An overdose of acetaminophen can harm 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 your sore throat lasts more than 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 in advance if you have taken Cough and Sore Throat Nighttime 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 interaction with this drug could happen. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not take more of this medication than is recommended. Taking too much acetaminophen can harm your liver or lead to death. Call your doctor immediately if you experience 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 notice 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 notice signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen can cause a severe skin reaction that may be life-threatening. This can happen even if you have taken acetaminophen before without any issues. Stop taking this medicine and call 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 containing acetaminophen again.

This medicine may cause serious side effects. Stop using it and call your doctor right away if you have:

• 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 Cough and Sore Throat Nighttime 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, take the missed dose as soon as you remember. If it is nearly time for your next scheduled dose, skip the missed dose. Do not take 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 may include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later signs can 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 medication. Acetaminophen (sometimes called APAP) is found in many combination medicines. Taking certain products together can lead to getting too much acetaminophen, which can result in a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

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

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

Ask a doctor or pharmacist before using Cough and Sore Throat Nighttime if you are taking any other medications, 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 Cough and Sore Throat Nighttime with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.