brompheniramine, dextromethorphan, and pseudoephedrine (AccuHist DM Pediatric Drops)

Brand Names: AccuHist DM Pediatric Drops, AccuHist PDX Drops (obsolete), Allanhist PDX Drops, Anaplex DM, Anaplex DMX, Andehist DM NR Syrup, Brom Tann, Bromadine-DM, Bromaline DM, Bromanate DX Cough, Bromatane DX, Bromaxefed DM RF Syrup, Bromdex D, Brometane DX, Bromfed DM, Bromhist PDX, Bromhist-DM Drops, Bromophed-DX, Bromph DM, Bromplex DM, Brotapp-DM, BroveX PSB DM, BroveX PSE DM, Carbofed DM Syrup, Cardec DM (obsolete), Dimetane DX, Dimetapp DM, EndaCof-DM (obsolete), Histacol BD Drops, Liquiphed DM, Myphetane DX, Myphetane DX Cough, Neo DM, Pediahist DM Drops, P-Hist DM Drops, ProHist DM, Q-Tapp DM, Resperal-DM Drops, Robitussin Allergy & Cough, Rondec-DM(obsolete), Sildec DM, Uni-Hist DM Pediatric Drops, Uni-Hist PDX Drops

Generic Name: brompheniramine, dextromethorphan, and pseudoephedrine

• What is brompheniramine, dextromethorphan, and pseudoephedrine?
• What are the possible side effects of brompheniramine, dextromethorphan, and pseudoephedrine?
• What is the most important information I should know about brompheniramine, dextromethorphan, and pseudoephedrine?
• What should I discuss with my healthcare provider before taking brompheniramine, dextromethorphan, and pseudoephedrine?
• How should I take brompheniramine, dextromethorphan, and pseudoephedrine?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid while taking brompheniramine, dextromethorphan, and pseudoephedrine?
• What other drugs will affect this medicine?
• Where can I get more information?

Brompheniramine 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.

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).

Brompheniramine, dextromethorphan, and pseudoephedrine is a combination medicine used to treat cough, runny or stuffy nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.

This medicine 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.

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

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

• confusion, severe anxiety, hallucinations, tremors;
• weak or shallow breathing;
• a light-headed feeling, like you might pass out;
• fast or pounding heartbeats;
• painful or difficult urination, 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 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.

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.

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.

Do not use brompheniramine, 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 brompheniramine, 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.

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.

QUESTION

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Since this 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.

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

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

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines and cough suppressants 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 or cough suppressant.

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Brompheniramine and pseudoephedrine can decrease sweating and you may be more prone to heat stroke.

Tell your doctor about all medicines you use, 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 brompheniramine, dextromethorphan, and pseudoephedrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

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

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