potassium guaiacolsulfonate/hydrocodone - oral, M-Clear, Prolex DH (cont.)
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to any of its ingredients; or to narcotic pain relievers (e.g., codeine, morphine); or if you have any other allergies.Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (e.g., chronic constipation, ileus, pancreatitis), adrenal gland problem (e.g., Addison's disease), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), breathing problems (e.g., asthma, emphysema), heart problems (e.g., irregular heartbeat), kidney disease, liver disease, mental/mood disorders (e.g., depression, psychosis), a certain spinal problem (kyphoscoliosis), underactive thyroid (hypothyroidism), trouble urinating (e.g., due to enlarged prostate or urethral stricture), use/abuse of drugs/alcohol.This drug may make you dizzy or drowsy or cause 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. Limit the use of alcohol and certain other medications that cause drowsiness. (See also Drug Interactions.)To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.This medicine may contain 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 medication safely.This medication may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about using this product safely.The elderly may be more sensitive to the effects of this drug, especially dizziness and drowsiness.Caution is advised when using this drug in children because they may be more sensitive to the effects of this medicine, especially slow/shallow breathing and drowsiness.During pregnancy, this medication should be used only if clearly needed. It is not recommended for use in high doses or for long periods during the last 3 months of pregnancy due to increased risk for serious side effects in a newborn baby (e.g., withdrawal symptoms such as irritability, abnormal/persistent crying, diarrhea, seizures). Tell the doctor immediately if you notice any of these symptoms in your newborn. Discuss the risks and benefits with your doctor.It is not known whether this product passes into breast milk. Consult your doctor before breast-feeding.
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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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