SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, headache, or vision changes may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these serious side effects occur: mental/mood changes. Tell your doctor immediately if this highly unlikely but very serious side effect occurs: change in the amount of urine. If you do not have liver problems, the adult maximum dose of acetaminophen is 4 grams per day (4000 milligrams). If you take more than the maximum daily amount, it may cause serious (possibly fatal) liver disease. Propoxyphene may also rarely cause liver disease. Tell your doctor immediately if you have any of the following symptoms of liver damage: severe nausea/vomiting, stomach/abdominal pain, yellowing eyes or skin, dark urine, extreme fatigue. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before taking propoxyphene with acetaminophen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal/stomach problems (e.g., severe diarrhea), alcohol use, breathing or lung disease (e.g., asthma, chronic obstructive pulmonary disease), difficulty urinating (e.g., enlarged prostate, urethral stricture), drug dependency, kidney disease, liver disease, mental/mood problems (e.g., depression, suicidal tendency, toxic psychosis), seizure disorders, serious head injury or brain disease. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcohol because it may increase the risk of side effects. 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 its side effects, especially drowsiness. 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. Propoxyphene with acetaminophen passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

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