HYDROCODONE/ACETAMINOPHEN-ORAL (cont.)
PRECAUTIONS: 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., respiratory depression, hypercapnia), severe diarrhea (e.g., pseudomembranous colitis, infectious diarrhea due to toxins). Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, difficulty urinating (e.g., enlarged prostate, urethral stricture), alcohol use, drug dependency, heart problems (e.g., slow/irregular heartbeat, very low blood pressure), abdominal/stomach problems (e.g., gallbladder disease), lung disease (e.g., asthma, chronic obstructive pulmonary disease), seizure disorders, serious head injury or brain disease, spinal problems (kyphoscoliosis), low thyroid disease (hypothyroidism), adrenal gland problems (Addison's disease), psychiatric problems (toxic psychosis), any allergies (especially to codeine or codeine-like medications). This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages because they may increase the risk of side effects of this drug. This product contains acetaminophen which may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Check with your doctor or pharmacist for more information. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially the possible decreased breathing and drowsiness effects. This medication should be used only when clearly needed during pregnancy. It is not recommended for use for long periods or in high doses near the expected delivery date because of the potential for fetal harm. Discuss the risks and benefits with your doctor. Based on information from related drugs, this drug may pass into breast milk. Due to the potential risk to the infant, consult your doctor before breast-feeding.
Report Problems to the Food and Drug Administration
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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