Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

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

Sudafed PE Children's Cold and Cough is a combination medicine used to treat cough, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Sudafed PE Children's Cold and Cough will not treat a cough that is caused by smoking, asthma, or emphysema.

Sudafed PE Children's Cold and Cough may also be used for purposes not listed in this medication guide.

Do not use Sudafed PE Children's Cold and Cough 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.

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

Call 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.

Do not give this medication 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.

Measure liquid medicine 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.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

You should not use Sudafed PE Children's Cold and Cough if you are allergic to dextromethorphan or phenylephrine.

Do not use Sudafed PE Children's Cold and Cough 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.

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

• high blood pressure;

• coronary artery disease (hardened arteries),

• diabetes;

• glaucoma;

• epilepsy or other seizure disorder;

• enlarged prostate or urination problems;

• pheochromocytoma (an adrenal gland tumor); or

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

FDA pregnancy category C. It is not known whether Sudafed PE Children's Cold and Cough will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

Dextromethorphan and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

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

Since Sudafed PE Children's Cold and Cough 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.

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

Sudafed PE Children's Cold and Cough may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of dextromethorphan and phenylephrine.

Ask a doctor or pharmacist before using any other cold, cough, or allergy medication. Sudafed PE Children's Cold and Cough 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 a decongestant or cough suppressant.

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.

Stop using Sudafed PE Children's Cold and Cough and call your doctor at once if you have:

• fast or uneven heart rate;

• severe dizziness or anxiety, feeling like you might pass out;

• severe headache;

• mood changes;

• fever; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Common side effects of Sudafed PE Children's Cold and Cough may include:

• diarrhea;

• dizziness, drowsiness;

• sleep problems (insomnia); or

• feeling nervous, restless, or irritable.

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 this medicine 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 Sudafed PE Children's Cold and Cough with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.