GENERIC NAME: PROMETHAZINE/PHENYLEPHRINE - ORAL (pro-METH-uh-zeen/fen-ill-EFF-rin)
WARNING: 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 (including some long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Do not use this product to make a child sleepy.
This product is not recommended for use in children younger than 2 years since it might cause serious (possibly fatal) slow/shallow breathing. In children 2 years and older, carefully follow the doctor's directions to use the lowest effective dose. Do not give more often than prescribed. Talk to the doctor or pharmacist before giving other cough-and-cold medication that might contain the same or similar ingredients that might also affect breathing. Get immediate medical help if you notice unusual slow/shallow breathing.
USES: See also Warning section.This combination medication is used to temporarily relieve symptoms caused by the common cold or allergies. Promethazine is an antihistamine that relieves watery eyes, itchy eyes/nose/throat, runny nose, and sneezing. Phenylephrine is a decongestant that helps relieve stuffy nose and ear congestion symptoms.Cough-and-cold products do not cure or shorten the length of the common cold and may cause serious side effects if not used properly. Ask your 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 as directed by your doctor, usually every 4 to 6 hours as needed. This medication may be taken with food if stomach upset occurs. Drink plenty of fluids when you use this medication unless otherwise directed by your doctor.Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.Tell your doctor if your condition persists for more than 1 week, if it worsens, or if it occurs with fever, rash, or persistent headache. These may be symptoms of a serious medical problem and should be checked by a doctor.
SIDE EFFECTS: Drowsiness, dizziness, headache, upset stomach, nausea, constipation, or dry mouth may occur. If any of these effects persist or worsen, tell 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: mental/mood changes (such as confusion, hallucinations), ringing in the ears, shaking (tremors), difficulty urinating, vision changes (such as blurred/double vision).Tell your doctor immediately if any of these rare but serious side effects occur: easy bruising/bleeding, slow/shallow breathing, involuntary behaviors/movements (such as fixed upward stare, neck twisting, tongue movements), seizure.This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.
PRECAUTIONS: See also Warning section.Before taking this medication, tell your doctor or pharmacist if you are allergic to promethazine or phenylephrine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/immune system problems (such as bone marrow depression), breathing problems (such as asthma, emphysema, sleep apnea), diabetes, glaucoma, heart problems (such as angina, irregular heartbeat), high blood pressure, liver problems, seizure, stomach/bowel problems (such as ulcer, blockage), overactive thyroid (hyperthyroidism), difficulty urinating (such as due to enlarged prostate).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.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.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Children may be more sensitive to the effects of the drug, especially slowed breathing. Young children may become excited/agitated instead of drowsy.Older adults may be more sensitive to the effects of the drug, especially dizziness, drowsiness, confusion, constipation, trouble urinating, trouble sleeping, or fast/irregular heartbeat. Dizziness, drowsiness, and confusion can increase the risk of falling.During pregnancy, this medication should be used only if clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), cabergoline, metoclopramide, pergolide.Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.This medication may interfere with certain laboratory tests (including some pregnancy tests, blood sugar tests, skin test for allergies), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, slowed breathing, seizure.
NOTES: Do not share this medication with others.Do not take this medication for several days before you have an allergy test because results can be affected.
MISSED DOSE: If you are taking this medication on a regular schedule and 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.
STORAGE: Store in a tightly closed container at room temperature between 68-77 degrees F (20-25 degrees C) away from light. 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 December 2013. Copyright(c) 2013 First Databank, Inc.
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