brompheniramine, dextromethorphan, and pseudoephedrine

What is the most important information I should know about brompheniramine, dextromethorphan, and pseudoephedrine?

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.

Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Brompheniramine, dextromethorphan, and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, cough suppressant, or decongestant.

Do not use brompheniramine, dextromethorphan, and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

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

Drinking alcohol can increase certain side effects of this medicine.

What is brompheniramine, dextromethorphan, and pseudoephedrine?

Brompheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

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

The combination of brompheniramine, dextromethorphan, and pseudoephedrine is used to treat sneezing, runny or stuffy nose, cough, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Brompheniramine, dextromethorphan, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking brompheniramine, dextromethorphan, and pseudoephedrine?

Do not use brompheniramine, dextromethorphan, and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Ask a doctor or pharmacist if it is safe for you to take brompheniramine, dextromethorphan, and pseudoephedrine if you have:

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

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Brompheniramine, dextromethorphan, and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take brompheniramine, dextromethorphan, and pseudoephedrine?

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 and 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.

Take this medicine with a full glass of water.

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.

Talk with 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.

If you need surgery, tell the surgeon ahead of time if you have taken a cough or cold medicine within the past few days.

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

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cough or cold medicine is taken when 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.

What happens if I overdose?

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

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking brompheniramine, dextromethorphan, and pseudoephedrine?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of brompheniramine, dextromethorphan, and pseudoephedrine.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Brompheniramine, dextromethorphan, and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine, cough suppressant, or decongestant.

What are the possible side effects of brompheniramine, dextromethorphan, and pseudoephedrine?

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

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• fast or pounding heartbeats;
• slow, shallow breathing;
• hallucinations, unusual thoughts or behavior;
• severe dizziness, anxiety, restless feeling, or nervousness;
• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure);
• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
• urinating less than usual or not at all.

Less serious side effects may include:

• dry mouth;
• nausea, stomach pain, constipation, mild loss of appetite, upset stomach;
• blurred vision;
• warmth, tingling, or redness under your skin;
• sleep problems (insomnia);
• feeling restless or excited (especially in children);
• mild skin rash or itching;
• dizziness, drowsiness, or headache; or
• problems with memory or concentration.

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.

What other drugs will affect brompheniramine, dextromethorphan, and pseudoephedrine?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by brompheniramine.

Tell your doctor about all other medications you use, especially:

• a diuretic (water pill), or blood pressure medicine;
• medication to treat irritable bowel syndrome;
• bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol), darifenacin (Enablex), or tolterodine (Detrol);
• salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Pepto-Bismol, Tricosal, and others;
• a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or
• antidepressants such as amitriptyline (Elavil, Vanatrip), clomipramine (Anafranil), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

This list is not complete and there may be other drugs that can interact with brompheniramine, dextromethorphan, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about brompheniramine, dextromethorphan, and pseudoephedrine.

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