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).

Acetaminophen, pheniramine, and phenylephrine 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.

Acetaminophen, pheniramine, and phenylephrine 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.

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 acetaminophen, pheniramine, and phenylephrine 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 acetaminophen, pheniramine, and phenylephrine will harm an unborn baby. Do not use cold or allergy medicine without a doctor's advice if you are pregnant.

This medicine 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.

Use Theraflu Cold & Sore Throat (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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 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 again take any medicine that contains acetaminophen.

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 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 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.