Dextromethorphan and phenylephrine

Dextromethorphan is a medicine that helps stop coughing. It works on the brain signals that make you cough.

Phenylephrine is a medicine that helps clear a stuffy nose by making the blood vessels in the nasal passages smaller. When blood vessels get larger, it can lead to nasal congestion (a stuffy nose).

Dextromethorphan and phenylephrine is a combination medicine used to treat cough, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Dextromethorphan and phenylephrine will not treat a cough caused by smoking, asthma, or emphysema.

Dextromethorphan and phenylephrine may also be used for other reasons that are not listed in this medication guide.

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.

Do not use dextromethorphan and phenylephrine if you have taken an MAO inhibitor in the last 14 days. A harmful drug interaction could happen. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use dextromethorphan and phenylephrine if you are allergic to dextromethorphan or phenylephrine.

Do not use dextromethorphan and phenylephrine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could happen. 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 dextromethorphan and phenylephrine 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.

Get emergency medical help if you notice any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Dextromethorphan and phenylephrine can cause serious side effects. Stop using dextromethorphan and phenylephrine and call your doctor immediately if you experience:

• fast or uneven heart rate;
• severe dizziness or anxiety, feeling faint;
• severe headache;
• mood changes;
• fever; or
• dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Common side effects of dextromethorphan and phenylephrine 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 happen. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Usual Pediatric Dose for Cough and Nasal Congestion:

Dextromethorphan 5 mg/ phenylephrine 2.5 mg per 5 mL liquid:6 to under 12 years: 10 mL every 4 hours4 to under 6 years: 5 mL every 4 hoursMaximum dose: 6 doses per 24 hours

Since dextromethorphan and phenylephrine is taken as needed, you may not have a set dosing schedule. If you are taking the medicine regularly, take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not take extra medicine to make up for the missed dose.

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

dextromethorphan and phenylephrine may cause blurred vision or affect your thinking or reactions. Be cautious if you drive or do anything that needs you to be alert and see clearly.

Drinking alcohol can make some side effects of dextromethorphan and phenylephrine worse.

Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Dextromethorphan and phenylephrine are in many combination medicines. Taking certain products together can lead to getting too much of a specific drug. Check the label to see if a medicine has a decongestant or cough suppressant.

Ask a doctor or pharmacist before using this medicine if you are taking any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when taken 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 dextromethorphan and phenylephrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.