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promethazine/phenylephrine - oral (cont.)

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.



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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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