Dexbrompheniramine, dextromethorphan, and pseudoephedrine

Dexbrompheniramine is an antihistamine that lowers the effects of histamine, a natural chemical in the body. Histamine can cause sneezing, itching, watery eyes, and a runny nose.

Dextromethorphan is a cough suppressant. It works on the brain signals that make you cough.

Pseudoephedrine is a decongestant that narrows blood vessels in the nasal passages. When blood vessels are swollen, it can lead to nasal congestion (a stuffy nose).

Dexbrompheniramine, dextromethorphan, and pseudoephedrine is a combination medicine used to relieve cough, runny or stuffy nose, sneezing, itching, and watery eyes due to allergies, the common cold, or the flu.

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

Dexbrompheniramine, dextromethorphan, and pseudoephedrine may also be used for other reasons not mentioned 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. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

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. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not take 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 or skin rash.

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 use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could happen. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Do not use dexbrompheniramine, dextromethorphan, and pseudoephedrine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

To make sure this medicine is safe for you, tell your doctor if you have:

• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
• a blockage in your digestive tract (stomach or intestines);
• high blood pressure, heart disease;
• liver or kidney disease;
• glaucoma;
• cough with mucus, or cough caused by emphysema or chronic bronchitis;
• enlarged prostate or urination problems;
• pheochromocytoma (an adrenal gland tumor);
• overactive thyroid; or
• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

FDA pregnancy category C. It is not known whether dexbrompheniramine, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

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

Get emergency medical help if you have any of these signs of an allergic reaction: hives; trouble 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:

• confusion, severe anxiety, hallucinations, tremors;
• weak or shallow breathing;
• feeling light-headed, as if you might faint;
• fast or pounding heartbeats;
• painful or hard time urinating, little or no urinating;
• pale skin, weakness, easy bruising or bleeding, fever, chills, body aches; or
• increased blood pressure—severe headache, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats.

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

• dizziness, drowsiness, headache;
• constipation, upset stomach, loss of appetite;
• blurred vision, double vision, dry eyes;
• sleep problems (insomnia); or
• dry mouth, nose, or throat.

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

This is not a complete list of side effects, and others may happen. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Cough and Nasal Congestion:

Dexbrompheniramine/dextromethorphan/pseudoephedrine 0.667 mg-10 mg-20 mg/5 mL oral liquid:15 mL orally every 6 hours not to exceed 60 mL daily.

Usual Pediatric Dose for Cough and Nasal Congestion:

Dexbrompheniramine/dextromethorphan/pseudoephedrine 0.667 mg-10 mg-20 mg/5 mL oral liquid:6 to 11 years: 7.5 mL orally every 6 hours not to exceed 30 mL daily12 years or older: 15 mL orally every 6 hours not to exceed 60 mL daily.

Since dexbrompheniramine, dextromethorphan, and pseudoephedrine is taken as needed, you might not have a regular dosing schedule. If you are taking the medication regularly and miss a dose, take it as soon as you remember. If it is nearly time for your next dose, skip the missed dose. Do not take extra medicine to compensate for the missed dose.

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

Drinking alcohol can make some side effects of dexbrompheniramine, dextromethorphan, and pseudoephedrine worse.

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Many combination medicines have antihistamines and cough suppressants. Taking certain products together can lead to taking too much of a specific drug. Check the label to see if a medicine has an antihistamine or cough suppressant.

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

Tell your doctor about all medicines you are using, 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 included in this medication guide.

Taking dexbrompheniramine, dextromethorphan, and pseudoephedrine with other drugs that make you sleepy or slow your breathing can make these effects worse. Ask your doctor before taking dexbrompheniramine, dextromethorphan, and pseudoephedrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.