Theraflu Daytime Severe Cold

You should not use this medicine if you are allergic to acetaminophen (Tylenol) or phenylephrine.

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.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:

• liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;

• high blood pressure, heart disease, coronary artery disease;

• overactive thyroid;

• pheochromocytoma (an adrenal gland tumor); or

• if you take an anti-depressant.

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

Acetaminophen and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use cough or cold medicine without a doctor's advice if you are pregnant.

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.

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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:

• fast, slow, or uneven heart rate;

• confusion, hallucinations;

• tremor, seizure (convulsions);

• little or no urinating;

• nausea, 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, seizure).

Common side effects may include:

• dizziness, weakness;

• mild headache;

• mild nausea, diarrhea, upset stomach;

• runny nose;

• feeling nervous, restless, or anxious; or

• sleep problems (insomnia).

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.

Other drugs may interact with acetaminophen and phenylephrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.