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February 10, 2012
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guaifenesin/hydrocodone - oral, Atuss EX, Cotuss-V, Entuss, Vo (cont.)

SIDE EFFECTS: Nausea, vomiting, constipation, dizziness, sleepiness, loss of appetite, nervousness, dry mouth, or blurred vision may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.To prevent constipation, maintain a diet adequate in fiber and drink plenty of water. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).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: difficulty staying awake, confusion, slow/shallow breathing, difficult/painful urination, irregular heartbeat, mental/mood changes (e.g., depression, hallucinations).Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures.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 guaifenesin/hydrocodone, tell your doctor or pharmacist if you are allergic to it; or to sulfites; or to other narcotics (e.g., codeine); or if you have any other allergies.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 breathing problems (e.g., severe chronic obstructive pulmonary disease-COPD, advanced emphysema), increased pressure in the brain (intracranial hypertension), certain bowel diseases (e.g., paralytic ileus), intoxication with medications which cause sleepiness or slow/shallow breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives).Before using this medication, tell your doctor or pharmacist your medical history, especially of: difficulty urinating (e.g., due to enlarged prostate, urethral stricture), personal or family history of regular use/abuse of drugs/alcohol, breathing problems (e.g., asthma, mild chronic obstructive pulmonary disease-COPD, moderate/severe sleep apnea), smoking, cough with large amounts of phlegm, kidney disease, liver disease, heart disease, low blood pressure, gallbladder/biliary tract problems, swollen pancreas (pancreatitis), certain brain problems (e.g., brain tumor, lesions), head injury, seizures, slow/irregular heartbeat, adrenal gland problems (e.g., Addison's disease), mental/mood disorders (e.g., toxic psychosis), a certain spine problem (kyphoscoliosis), recent surgery, underactive thyroid (hypothyroidism), a severe loss of body water (dehydration), severe obesity, stomach pain of unknown cause.This drug may cause dizziness, drowsiness, or blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects (e.g., slow/shallow breathing, drowsiness, dizziness).Caution is advised when using this drug in children because they may be more sensitive to its side effects (e.g., slow/shallow breathing, drowsiness, dizziness).This medication should be used only when clearly needed during pregnancy. It is not recommended for use over long periods or in high doses near the expected delivery date because it may harm the unborn baby. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.



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