M-End DMX

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.

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.

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.

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.

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 occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take M-END DMX. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take this medicine for longer than you were told by your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how M-END DMX affects you.
• Avoid drinking alcohol while taking this medicine.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using M-END DMX while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about M-END DMX (pseudoephedrine/dexbrompheniramine/dextromethorphan liquid), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about M-END DMX. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using M-END DMX.

Review Date: October 4, 2017

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of M-End DMX may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.