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February 10, 2012
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theophylline/guaifenesin - oral, Quibron, Slo-Phyllin GG, Theom (cont.)

SIDE EFFECTS: Nausea, vomiting, headache, trouble sleeping, diarrhea, irritability, restlessness, shaking, increased urination, and stomach pain/cramping 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 rare but serious side effects occur: fast/irregular heartbeat, seizures.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: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as dyphylline); or if you have any other allergies.Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as angina, fast/irregular heartbeat, heart failure, recent heart attack), high blood pressure, kidney disease, liver disease, seizures, stomach/intestinal ulcer, thyroid problems (underactive or overactive), a certain lung problem (cystic fibrosis), fluid in the lungs.Common illnesses may affect how this medication is removed from your body. Tell your doctor immediately if you develop a high fever (102 degrees F/39 degrees C or higher) that lasts for more than 24 hours. The dose of your medication may need to be adjusted.This medication contains aspartame. 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 product safely.Before having surgery, tell your doctor or dentist that you are using this medication.This medication may be used during pregnancy as directed by your doctor. Tell your doctor if you are pregnant because your dose may need to be adjusted.This medication passes into breast milk. However, it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.



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