Dexbrompheniramine, dextromethorphan, and phenylephrine

Dexbrompheniramine is an antihistamine that helps reduce the effects of histamine in the body. Histamine can cause symptoms like sneezing, itching, watery eyes, and a runny nose.

Dextromethorphan is a cough suppressant. It works on signals in the brain that cause the cough reflex.

Phenylephrine is a decongestant that narrows blood vessels in the nasal passages. When blood vessels are dilated, they can lead to nasal congestion (a stuffy nose).

Dexbrompheniramine, dextromethorphan, and phenylephrine is a combination medicine used to relieve runny or stuffy nose, sneezing, itching, watery eyes, cough, and sinus congestion caused by allergies, the common cold, or the flu.

Dexbrompheniramine, dextromethorphan, and phenylephrine will not treat a cough that is caused by smoking, asthma, or emphysema.

Dexbrompheniramine, dextromethorphan, and phenylephrine may also be used for other reasons not listed in this medication guide.

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

Always follow directions on the medicine label about giving cough or cold medicine to a child. Do not use the medicine only to make a child sleepy. Death can occur from the misuse of cough or cold medicines in very young children.

Measure liquid medicine 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 or medical tests, tell the surgeon or doctor if you have taken a cough or cold medicine within the past few days.

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

Do not use dexbrompheniramine, dextromethorphan, and phenylephrine 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 use cough or cold medicine to make a child sleepy.

You should not use this medicine if you are allergic to dexbrompheniramine, dextromethorphan, or phenylephrine.

Do not use cough or cold medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous interaction could happen. MAO inhibitors include furazolidone, isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

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

• asthma or COPD;
• a cough with mucus, or a cough caused by chronic bronchitis;
• a blockage in your stomach or intestines;
• glaucoma;
• liver or kidney disease;
• diabetes;
• heart disease, high blood pressure;
• a thyroid disorder; or
• urination problems.

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

Liquid medicine may contain phenylalanine. Check the medication label if you have phenylketonuria (PKU).

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

This medicine may cause serious side effects. Stop using this medicine and call your doctor right away if you have:

• fast, pounding, or irregular heartbeats;
• shortness of breath;
• severe dizziness or nervousness;
• little or no urination;
• trouble sleeping; or
• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.

Common side effects of dexbrompheniramine, dextromethorphan, and phenylephrine may include:

• flushing (warmth, redness, or tingly feeling);
• dry mouth, nose, or throat;
• feeling nervous, restless, or irritable;
• dizziness, drowsiness;
• feeling restless or excited (especially in children);
• loss of appetite;
• blurred vision; 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.

Usual Adult Dose for Cough and Nasal Congestion:

Dexbrompheniramine 2 mg/dextromethorphan 20 mg/phenylephrine 10 mg/5 mL oral syrup:5 mL orally 4 times daily.Dexbrompheniramine 6 mg/dextromethorphan 30 mg/phenylephrine 20 mg oral tablets, extended release:1 tablet orally 2 times daily not to exceed 2 tablets daily.

Usual Pediatric Dose for Cough and Nasal Congestion:

Dexbrompheniramine 2 mg/dextromethorphan 20 mg/phenylephrine 10 mg/5 mL oral syrup:>=6 yrs to <12 yrs: 2.5 mL orally 4 times daily.>=12 yrs: 5 mL orally 4 times daily.Dexbrompheniramine 6 mg/dextromethorphan 30 mg/phenylephrine 20 mg oral tablets, extended release:>=6 yrs to <12 yrs: 0.5 tablet orally 2 times daily not to exceed 1 tablet daily.>=12 yrs: 1 tablet orally 2 times daily not to exceed 2 tablets daily.

Since dexbrompheniramine, dextromethorphan, and phenylephrine is taken as needed, you might not have a regular dosing schedule. If you miss a dose and it's nearly time for your next dose, just skip the missed dose. Do not take two doses at the same time.

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

Drinking alcohol with dexbrompheniramine, dextromethorphan, and phenylephrine can cause side effects.

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

Avoid driving or doing anything dangerous until you know how this medicine will affect you. Your reactions could be impaired.

Avoid using this medicine with other drugs that can make you drowsy or slow your breathing (like opioid medicine, a muscle relaxer, or medicine for anxiety or seizures). Ask a doctor or pharmacist before using any other medication, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed in this medication guide.