Propoxyphene should be used with extreme caution, if at all, in patients who have a history of substance/drug/alcohol abuse, depression with suicidal tendency, or who already take medications that cause drowsiness (e.g., antidepressants, muscle relaxants, pain relievers, sedatives, tranquilizers). Fatalities have occurred in such patients when propoxyphene was misused.

It is important not to take more of this medication than prescribed.

This combination medication is used to treat mild to moderate pain. Propoxyphene is a narcotic pain reliever (opiate-type) that acts on certain centers in the brain to give you pain relief. Acetaminophen is a non-narcotic pain reliever.

Take this medication by mouth as directed by your doctor. It may be taken with food if stomach upset occurs, however, the drug may not work as well. Consult your doctor or pharmacist about other ways to reduce stomach upset (e.g., antihistamines, lying down for 1-2 hours with minimal head movement).

Dosage is based on your medical condition and response to therapy. Pain medications work best if used when the first signs of pain occur. If you wait until the pain worsens, the medication may not work as well.

Use this medication exactly as prescribed. Do not exceed the maximum daily dose of propoxyphene hydrochloride (390 milligrams per day).

Do not increase your dose, take it more often or use it longer than prescribed because it can be habit-forming. If this drug is prescribed for an extended period of time, do not suddenly stop using it without your doctor's approval.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

This medication contains acetaminophen. Do not take more of it than recommended (see Side Effects section).

Inform your doctor if your pain persists or worsens.

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.

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 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. Seek immediate medical attention 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.

If you have liver problems, consult your doctor or pharmacist for a safe dosage of this medication.

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 (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.

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. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

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 harm to an unborn baby. 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.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because very serious interactions may occur: naltrexone.

If you are currently using this medication, tell your doctor or pharmacist before starting propoxyphene/acetaminophen.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), carbamazepine, cimetidine, MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), other pain medications, tricyclic antidepressants (e.g., doxepin).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: anti-anxiety drugs (e.g., diazepam), antidepressants (e.g., amitriptyline), antihistamines that cause drowsiness (e.g., diphenhydramine), anti-seizure drugs (e.g., phenobarbital), medicine for sleep (e.g., sedatives), muscle relaxants, psychiatric medicines (e.g., phenothiazines such as chlorpromazine), tranquilizers.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about the safe use of those products.

In addition, check the labels on other pain relievers, fever reducers, or cold products before you take them to see if they contain acetaminophen (see Side Effects section). Consult your pharmacist for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include slow breathing, slow heartbeat, loss of consciousness, seizures, severe nausea/vomiting/stomach pain, cold/clammy skin, unusual sweating.

Do not share this medication with others. It is against the law.

This medication has been prescribed for your current condition only. Do not use it later for other conditions unless directed by your doctor. A different medication may be necessary in those cases.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type).

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.