promethazine/phenylephrine - oral (cont.)

HOW TO USE: Take this medication by mouth with or without food, usually every 4-6 hours or as directed by your doctor. This medication may be taken with food if stomach upset occurs.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.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 infrequently cause a very serious (rarely fatal) 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, irregular/fast heartbeat, 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 pharmacistIn 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.

Report Problems to the Food and Drug Administration

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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