promethazine w/dextromethorphan - oral, Phenergan w/Dextromethorphan (cont.)

USES: This medication is used to treat runny nose, coughing, sneezing, itchy nose/throat, and itchy/watery eyes caused by the common cold, allergies, hay fever, sinusitis, and other breathing illnesses. Promethazine works like an antihistamine. It blocks the effects of a certain natural chemical (histamine), which causes cold/allergy symptoms. Dextromethorphan belongs to a class of drugs known as cough suppressants. It acts on a part of the brain (cough center) to reduce the need to cough.Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

HOW TO USE: Take this medication by mouth with or without food, usually every 4-6 hours or as directed by your doctor.Dosage is based on your medical condition and response to treatment. Carefully measure your prescribed dose using a medication-measuring device or spoon. Do not use a household spoon because you may not get the correct dose.Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day.Improper use of this medication (abuse) may result in serious harm (e.g., brain damage, seizure, death). Do not increase your dose, take it more frequently, or use it for a longer time than directed.Inform your doctor if your condition persists or worsens after 7 days.

SIDE EFFECTS: Drowsiness, dizziness, headache, upset stomach, nausea, or dry mouth/nose/throat may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/slow/irregular heartbeat, difficulty breathing, vomiting, decreased coordination, fainting, ringing in the ears, vision changes (e.g., blurred/double vision), difficulty urinating, shaking (tremor), mental/mood changes (e.g., nervousness, irritability, confusion, hallucinations).Stop taking this medication and seek immediate medical attention if any of these rare but very serious side effects occur: slow/shallow breathing, signs of infection (e.g., fever, persistent sore throat), severe abdominal pain, persistent nausea/vomiting, easy bleeding/bruising, yellowing of eyes/skin, dark urine, abnormal/involuntary movements (e.g., fixed upward stare, neck twisting, tongue movements).Promethazine may rarely cause a very serious nervous system disorder (neuroleptic malignant syndrome). If you notice any of the following rare but very serious side effects, stop taking this medication and seek immediate medical attention: severe muscle stiffness, mental/mood changes (e.g., sudden confusion, extreme drowsiness), very high fever, seizures, increased sweating.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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