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Drug Information For: DARVOCET-N 100 TABLETS

Ingredient Name: PROPOXYPHENE (proe-POX-i-feen) and ACETAMINOPHEN (a-seat-a-MIN-oh-fen)

Drug Manufacturer: AAIPHARMA

Common Uses: This medicine is a combination of a narcotic analgesic and acetaminophen used to relieve mild to moderate pain.

Before Using This Medicine: WARNING: Propoxyphene should be used with extreme caution, and if possible not at all, in people who abuse alcohol; have a history of abuse of alcohol or other substances; have a history of emotional problems or suicidal thoughts or attempts; or who already take drowsiness-causing medicines such as antidepressants, barbiturates, muscle relaxants, pain relievers, or sedatives. Deaths have occurred in such patients when propoxyphene was misused. Patients must not take more propoxyphene than prescribed. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking sodium oxybate. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking "blood thinners" (such as warfarin), cimetidine, medicine for seizures (such as carbamazepine or phenytoin), isoniazid, medicine for depression or other mental or mood disorders, ritonavir, or other medicines that may cause drowsiness (such as antidepressants, barbiturates, muscle relaxants, pain relievers, or sedatives). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including asthma, severe inflammatory bowel problems, liver or kidney problems, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have severe diarrhea problems (such as pseudomembranous colitis). Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. This medicine may come with a patient information leaflet. Ask your doctor, nurse, or pharmacist any questions you may have about this medicine. THIS MEDICINE MAY BE TAKEN WITH FOOD if it upsets your stomach. STORE THIS MEDICINE at room temperature in a tightly-closed container, away from heat and light. IF YOU MISS A DOSE OF THIS MEDICINE and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Cautions: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. THIS MEDICINE WILL ADD TO THE EFFECTS of alcohol and other depressants. Ask your doctor or pharmacist if you have questions about which medicines are depressants. THIS MEDICINE CONTAINS ACETAMINOPHEN. Do not take additional acetaminophen for pain or fever without checking with your doctor or pharmacist. Ask your pharmacist if you have questions about which medicines contain acetaminophen. Acetaminophen may cause liver damage. IF YOU DRINK 3 OR MORE ALCOHOL-CONTAINING DRINKS A DAY, do not take this medicine without first discussing it with your doctor. Alcohol use combined with acetaminophen may increase your risk for liver damage. THIS MEDICINE MAY CAUSE DIZZINESS OR DROWSINESS. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. This includes medicines for pain, allergies, or sinus problems. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of the medicine. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.

Possible Side Effects: SIDE EFFECTS, that may go away during treatment, include dizziness, drowsiness, lightheadedness, headache, constipation, nausea, or vomiting. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience vision changes. CONTACT YOUR DOCTOR IMMEDIATELY if you experience yellowing of eyes or skin, dark urine, unusual itching, prolonged stomach pain, mental or mood changes, hallucinations, or muscle pain. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Overdose: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include unusual sleepiness; slow, shallow breathing; cold, clammy skin; seizures; nausea; vomiting; excessive sweating; dark urine; stomach pain; extreme fatigue; and loss of consciousness.
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