Promethazine should not be used in children younger than 2 years since it might cause serious (possibly fatal) slow/shallow breathing. This problem has occurred even with normal doses in this age group. The lowest effective dosage should be used, and other drugs that affect breathing should be avoided. Seek immediate medical attention in the unlikely event that slow/shallow breathing occurs. Promethazine should not be used in children with liver disease (including possible Reyes syndrome).

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).

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.

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.

See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to any other phenothiazines (e.g., prochlorperazine); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., angina, irregular heartbeat), kidney/liver problems, breathing problems (e.g., asthma, emphysema, sleep apnea), difficulty urinating (e.g., due to an enlarged prostate), stomach/bowel problems (e.g., blockage, ulcer), high blood pressure, overactive thyroid (hyperthyroidism), diabetes, a certain eye problem (narrow-angle glaucoma), seizures, blood/immune system problems (e.g., bone marrow depression).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Children should be supervised to avoid injury during bicycle riding or other possibly hazardous activities. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly from a sitting or lying position.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Liquid forms of this medication may contain sugar, alcohol, or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Children may be more sensitive to the effects of the drug, especially breathing problems such as slow/shallow breathing. Children may also experience excitability rather than drowsiness. Special caution should be taken in children with a family history of sudden infant death syndrome (SIDS), those who have a severe loss of fluid (dehydration), and those who are hard to wake up from sleep.

The elderly may be more sensitive to the effects of the drug, especially drowsiness and confusion.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. However, it may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), epinephrine for low blood pressure, metrizamide, sibutramine, cabergoline, pergolide, halofantrine, pimozide.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.

Tell your doctor or pharmacist if you have stopped taking MAO inhibitors within the last 2 weeks.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: narcotic pain medications (e.g., codeine), tramadol, memantine, muscle relaxants, medicine for sleep/anxiety (e.g., alprazolam, diazepam, zolpidem), bupropion, tricyclic antidepressants (e.g., amitriptyline), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone), drugs for Parkinson's disease (e.g., anticholinergics such as benztropine, trihexyphenidyl), anti-seizure drugs (e.g., carbamazepine), scopolamine, antispasmodics (e.g., atropine, belladonna alkaloids), other antihistamines (e.g., diphenhydramine, dimenhydrinate), cough-and-cold products, diphenhydramine or other antihistamines applied to the skin (e.g., anti-itch cream, ointment, spray).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: nausea, vomiting, blurred vision, drowsiness, slowed breathing, widened/fixed pupils, seizures, deep sleep, loss of consciousness.

Do not share this medication with others.

Unless otherwise directed by your physician, drink plenty of fluids (especially water) while taking this medication. It will help to break up mucus and clear congestion.

Do not take this medication for several days before you have an allergy test because results can be affected.

Promethazine may affect the results of some pregnancy tests. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember.

If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light. Keep the container tightly closed. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised March 2009 Copyright(c) 2009 First DataBank, Inc.