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

Sudafed is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

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

Do not give Sudafed 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. Pseudoephedrine 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 pseudoephedrine or a decongestant. Do not use Sudafed if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medicine

Do not use Sudafed if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Do not use Sudafed if you are allergic to pseudoephedrine or to other decongestants, diet pills, stimulants, or ADHD medications.

Ask a doctor or pharmacist if it is safe for you to take Sudafed if you have:

• heart disease or high blood pressure;

• diabetes; or

• a thyroid disorder.

FDA pregnancy category C. It is not known whether Sudafed will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Sudafed. Pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use Sudafed without telling your doctor if you are breast-feeding a baby.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

Use Sudafed 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. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give Sudafed 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.

Take Sudafed with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. You may need to shake the oral suspension (liquid) well just before you measure a dose. Measure the Sudafed liquid with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one.

Do not take Sudafed for longer than 7 days in a row. Talk with your 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. If you need surgery, tell the surgeon ahead of time that you are using Sudafed. You may need to stop using the medicine for a short time.

Store Sudafed at room temperature away from moisture and heat.

Do not use Sudafed if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Do not use Sudafed if you are allergic to pseudoephedrine or to other decongestants, diet pills, stimulants, or ADHD medications.

Ask a doctor or pharmacist if it is safe for you to take Sudafed if you have:

• heart disease or high blood pressure;

• diabetes; or

• a thyroid disorder.

FDA pregnancy category C. It is not known whether Sudafed will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Sudafed. Pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use Sudafed without telling your doctor if you are breast-feeding a baby.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

Since Sudafed is taken as 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.

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

Overdose symptoms may include feeling restless or nervous.

Avoid taking Sudafed if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cough or cold medicine. Sudafed 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 Sudafed or a decongestant.

Get emergency medical help if you have any of these signs of an allergic reaction to Sudafed: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Sudafed and call your doctor at once if you have a serious side effect such as:

• fast, pounding, or uneven heartbeat;

• severe dizziness or anxiety;

• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

• dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing, uneven heart rate, seizure).

Less serious Sudafed side effects may include:

• loss of appetite;

• warmth, tingling, or redness under your skin;

• feeling restless or excited (especially in children);

• sleep problems (insomnia); or

• skin rash or itching.

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.

Tell your doctor about all other medicines you use, especially:

• blood pressure medications;

• a beta blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

• an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others.

This list is not complete and other drugs may interact with Sudafed. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.