Acetaminophen is a pain reliever and a fever reducer.

Pheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Theraflu Flu & Sore Throat is a combination medicine used to treat headache, runny nose, sneezing, stuffy nose, sinus congestion, watery eyes, and pain or fever caused by allergies, the common cold, or the flu.

Theraflu Flu & Sore Throat may also be used for other purposes not listed in this medication guide.

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 cold or allergy 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.

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 take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

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

Dissolve the contents of one packet of medicine in 8 ounces of hot water. You may also mix the powder with 8 ounces of cool water and heat the mixture in a microwave oven. Stir the mixture thoroughly before and after heating it. Sip the mixture slowly, making sure you finish all of it within 10 to 15 minutes.

Do not take more than 6 packets of this medicine in one day (24 hours).

Call doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store at room temperature away from moisture and heat.

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.

You should not use this medication if you are allergic to acetaminophen (Tylenol) or chlorpheniramine, or if you have:

• severe constipation, blockage in your stomach or intestines;

• untreated or uncontrolled diseases--glaucoma, asthma or COPD, heart disease, high blood pressure, coronary artery disease, overactive thyroid; or

• if you are unable to urinate.

Do not use cold or allergy 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.

Ask a doctor or pharmacist if it is safe for you to take Theraflu Flu & Sore Throat if you have other medical conditions, especially:

• kidney disease;

• cough with mucus, or cough caused by emphysema or chronic bronchitis;

• an enlarged prostate, problems with urination;

• a history of alcoholism; or

• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

It is not known whether Theraflu Flu & Sore Throat will harm an unborn baby. Do not use cold or allergy medicine without a doctor's advice if you are pregnant.

Theraflu Flu & Sore Throat may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use cold or allergy without a doctor's advice if you are breast-feeding a baby.

Always ask a doctor before giving a cold or allergy medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Since Theraflu Flu & Sore Throat is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

The first signs of an acetaminophen overdose include 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 abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much 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 increase your risk of liver damage while taking acetaminophen.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult 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 occur even if you have taken acetaminophen in the past and had no reaction. Stop taking Theraflu Flu & Sore Throat 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 again take any medicine that contains acetaminophen.

The medicine may cause serious side effects. Stop using the medicine and call your doctor at once if you have:

• chest pain, rapid pulse, fast or uneven heart rate;

• confusion, hallucinations, tremor, severe dizziness or anxiety;

• slow, shallow breathing;

• little or no urinating;

• easy bruising or bleeding, unusual weakness;

• nausea, pain in your 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, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Common side effects of Theraflu Flu & Sore Throat may include:

• dryness of the eyes, nose, and mouth;

• blurred vision;

• dizziness, drowsiness, problems with memory or concentration;

• ringing in your ears;

• feeling restless or irritable; or

• mild nausea, stomach pain, constipation.

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.

Ask a doctor or pharmacist before using Theraflu Flu & Sore Throat if you are also using 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 listed in this medication guide.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking Theraflu Flu & Sore Throat with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.