Dexbrompheniramine and pseudoephedrine

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

Pseudoephedrine is a decongestant that narrows blood vessels in the nasal passages. Swollen blood vessels can lead to nasal congestion (a stuffy nose).

Dexbrompheniramine and pseudoephedrine is a combination medicine used to treat symptoms of the common cold or seasonal allergies, including sneezing, a runny or stuffy nose, and itchy, watery eyes.

Dexbrompheniramine and pseudoephedrine 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 larger or smaller amounts or for longer than recommended. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving this medicine to a child younger than 6 years old. You should not use antihistamine medication to make a child sleepy. Death can occur from the misuse of cough and cold medicines in very young children.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

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.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need surgery, tell the surgeon ahead of time if you have taken a cold 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, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

You should not use antihistamine medication to make a child sleepy.

You should not use dexbrompheniramine and pseudoephedrine if you are allergic to dexbrompheniramine or pseudoephedrine.

Do not use this medicine 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.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:

• heart disease or high blood pressure;
• a thyroid disorder;
• glaucoma;
• diabetes; or
• an enlarged prostate with urination problems.

It is not known whether dexbrompheniramine and pseudoephedrine will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

It is not known whether dexbrompheniramine and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Ask a doctor before using this medicine if you are breast-feeding a baby. Antihistamines and decongestants may slow breast milk production.

Artificially sweetened liquid 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 have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

dexbrompheniramine and pseudoephedrine may cause serious side effects. Stop using dexbrompheniramine and pseudoephedrine and call your doctor right away if you have:

• severe nervousness;
• a light-headed feeling, like you might faint;
• trouble sleeping;
• fast or uneven heart rate; or
• painful or difficult urination.

Side effects may be more likely in older adults.

Common side effects of dexbrompheniramine and pseudoephedrine may include:

• drowsiness;
• feeling restless or excited (especially in children);
• blurred vision; or
• dry nose or mouth.

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.

Since cold medicine is taken when needed, you might not have a regular dosing schedule. If you are taking the medication 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 attention or call the Poison Help line at 1-800-222-1222.

Avoid drinking alcohol. It may increase side effects of dexbrompheniramine and pseudoephedrine.

Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Many combination medicines contain dexbrompheniramine or pseudoephedrine. Taking certain products together can cause you to get too much of a certain medicine. Check the label to see if a medicine contains an antihistamine or decongestant.

Dexbrompheniramine and pseudoephedrine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Ask a doctor or pharmacist before using this medicine if you are also taking 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 make these effects worse. Ask your doctor before taking dexbrompheniramine and pseudoephedrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.