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February 10, 2012
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guaifenesin/ephedrine - oral liquid, Broncholate (cont.)

SIDE EFFECTS: Mild stomach upset, trouble sleeping, dizziness, lightheadedness, headache, nervousness, fast heartbeat, loss of appetite, diarrhea, shaking, or unusual sweating may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.This product may reduce blood flow to your hands and feet, causing them to feel cold. Smoking may worsen this effect. Dress warmly and avoid tobacco use.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. Notify your doctor immediately if any of these unlikely but serious side effects occur: fast irregular heartbeat, severe/uncontrolled shaking, difficulty urinating, decreased sexual ability, mental/mood changes (e.g., anxiety, panic, hallucinations).Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, seizures, slurred speech, weakness on one side of the body.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 medication, tell your doctor or pharmacist if you are allergic to ephedrine or guaifenesin; or if you have any other allergies. Also tell your doctor if you have had a negative reaction to other sympathomimetics (e.g., pseudoephedrine, phenylephrine).This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe asthma, severe high blood pressure, heart disease (e.g., severe coronary artery disease, angina, heart failure), certain types of fast heart rhythm problems (e.g., atrial fibrillation/flutter, paroxysmal supraventricular tachycardia-PSVT), a certain slow heart rhythm problem (sinus bradycardia), certain eye problems (closed-angle glaucoma), difficulty urinating (e.g., due to enlarged prostate).Before using this medication, tell your doctor or pharmacist your medical history, especially of: stroke, high blood pressure, chest pain (angina), heart attack, smoking, long-term breathing problems (e.g., asthma, chronic bronchitis, emphysema), cough with large amounts of phlegm, mental/mood disorders (e.g., anxiety, bipolar disorder, mania), epilepsy/seizure problems, certain blood vessel problems (e.g., Raynaud's disease, peripheral vascular disease), overactive thyroid (hyperthyroidism), low blood flow to the brain (cerebral insufficiency), diabetes, difficulty sleeping, certain adrenal gland problem (pheochromocytoma).This drug may make you dizzy. 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.Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially dizziness and lightheadedness.Caution is advised when using this product in children because they may be more sensitive to its side effects, especially excitation, agitation, and increased blood pressure. Consult your doctor before using in a child 12 or younger.This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.The ephedrine in this product passes into breast milk. It is not known whether guaifenesin passes into breast milk. Breast-feeding while using this product is not recommended. Consult your doctor before breast-feeding.



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