Drixoral Cold and Allergy contains a combination of dexbrompheniramine and pseudoephedrine. Dexbrompheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

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

Drixoral Cold and Allergy is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Drixoral Cold and Allergy may also be used for purposes not listed in this medication guide.

Do not use Drixoral Cold and Allergy if you have used 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.

Do not use Drixoral if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid.

You should not use this medicine if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

Use Drixoral Cold and Allergy 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. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving Drixoral Cold and Allergy 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.

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

Do not use Drixoral Cold and Allergy 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 Drixoral Cold and Allergy 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 Drixoral Cold and Allergy will harm an unborn baby. Ask a doctor before using Drixoral Cold and Allergy 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.

Since cold medicine is taken as 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.

Avoid drinking alcohol. It may increase side effects of Drixoral Cold and Allergy.

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.

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

Get emergency medical help if you have signs of an allergic reaction to Drixoral Cold and Allergy: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• severe nervousness;

• a light-headed feeling, like you might pass out;

• trouble sleeping;

• fast or uneven heart rate; or

• painful or difficult urination.

Side effects may be more likely in older adults.

Common Drixoral Cold and Allergy side effects 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.

Ask a doctor or pharmacist before using Drixoral Cold and Allergy 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 Drixoral Cold and Allergy with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.