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February 10, 2012
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guaifenesin/dextromethorphan - oral, Recofen (cont.)

SIDE EFFECTS: Dizziness, drowsiness, upset stomach, and nausea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.If your doctor has directed you to use this medication, remember that 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.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.

PRECAUTIONS: Before taking this drug, tell your doctor or pharmacist if you are allergic to guaifenesin or dextromethorphan; or if you have any other allergies. Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, emphysema), liver problems, diabetes.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. Limit alcoholic beverages.Liquid preparations of this product may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about the safe use of this product.The rapidly-dissolving granules may contain phenylalanine. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this drug safely.This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor.This medication passes into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.



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