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

Sudafed PE is used to treat stuffy nose and sinus congestion caused by the common cold, hay fever, or other allergies.

Sudafed PE may also be used for purposes not listed in this medication guide.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Do not give Sudafed PE to a child younger than 4 years old. 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. Ask a doctor or pharmacist before using any other cough or cold medicine. Phenylephrine or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains phenylephrine or a decongestant.

Before taking this medicine

Do not use Sudafed PE if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use Sudafed PE if you are allergic to phenylephrine.

Ask a doctor or pharmacist if this medicine is safe to use if you have:

• heart disease, high blood pressure;

• diabetes;

• a thyroid disorder;

• an enlarged prostate and urination problems; or

• any drug allergies.

Ask a doctor before using this medicine if you are pregnant or breast-feeding.

Use Sudafed PE exactly as directed on the label, or as prescribed by your doctor. Cold medicine is only for short-term use until your symptoms clear up.

Always follow directions on the medicine label about giving cold medicine to a child.

Measure liquid medicine (Children's Sudafed PE Nasal Decongestant) carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Call your doctor if your symptoms do not improve after 7 days, or if you have a fever, rash, or headaches.

If you need surgery, tell your surgeon if you are currently using this medicine.

Store at room temperature away from moisture and heat. Do not freeze.

Do not use Sudafed PE if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use Sudafed PE if you are allergic to phenylephrine.

Ask a doctor or pharmacist if this medicine is safe to use if you have:

• heart disease, high blood pressure;

• diabetes;

• a thyroid disorder;

• an enlarged prostate and urination problems; or

• any drug allergies.

Ask a doctor before using this medicine if you are pregnant or breast-feeding.

Since cold medicine is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's almost time for your next dose. Do not use two doses at one time.

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

Ask a doctor or pharmacist before using other cough or cold medicines that may contain similar ingredients.

Get emergency medical help if you have signs of an allergic reaction to Sudafed PE: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Sudafed PE and call your doctor at once if you have:

• fast, pounding, or irregular heartbeat;

• severe dizziness or nervousness;

• sleep problems (insomnia); or

• increased blood pressure - severe headache, blurred vision, pounding in your neck or ears.

Common Sudafed PE side effects may include:

• flushing (warmth, redness, or tingly feeling);

• loss of appetite; or

• feeling restless or excited (especially in children).

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.

Many drugs can interact with phenylephrine, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.