Children and teenagers should not use aspirin or medications that contain or are similar to aspirin for flu symptoms or chickenpox without first consulting a doctor. A rare but serious illness known as Reye's syndrome may occur.

Propoxyphene has caused death when taken in large doses, either alone or with alcohol/drugs that can cause drowsiness (e.g., certain antidepressants, sedatives, muscle relaxants). Do not take more of this medication, take it more often, or use a larger dose than prescribed. Limit alcoholic beverages. See also Drug Interactions section.

This combination medication is used to treat moderate pain, fever, and swelling. Propoxyphene is a narcotic pain reliever (opiate-type) that acts on certain centers in the brain to give you pain relief. Aspirin helps to decrease the pain, fever, and swelling. Caffeine helps increase the effects of aspirin on pain.

Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth as directed by your doctor. Take with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 30 minutes after taking this medication. If you have nausea, you may take this medication with food. Consult your doctor or pharmacist about other ways to decrease nausea (e.g., antihistamines, lying down for 1 to 2 hours with as little head movement as possible).

The dosage is based on your medical condition and response to treatment. Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

This medication may cause dependence, especially if it has been used regularly for an extended time or if it has been used in high doses. In such cases, withdrawal reactions (e.g., runny nose, watery eyes, restlessness) may occur if you suddenly stop this drug. To prevent withdrawal reactions when stopping extended, regular treatment with this drug, gradually reduce the dosage as directed. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

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.

Tell your doctor if your pain persists or worsens.

Nausea, vomiting, stomach upset, shaking (tremor), constipation, dry mouth, lightheadedness, flushing, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

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 with stool softener).

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 unlikely but serious side effects occur: mental/mood changes, fainting, seizure, fast/irregular heartbeat, increased thirst/urination, slow/shallow breathing, hearing changes (e.g., ringing in the ears), easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), heartburn, discomfort when swallowing, dark urine, yellowing eyes/skin, change in the amount of urine, unusual tiredness.

Seek immediate medical attention if any of these rare but very serious side effects occur: black stools, severe stomach/abdominal pain, vomit that looks like coffee grounds, slurred speech, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 this medication, tell your doctor or pharmacist if you are allergic to aspirin, caffeine, or narcotic pain medications (e.g., methadone, morphine); or to salicylates (e.g., salsalate), nonsteroidal anti-inflammatory drugs (e.g., ibuprofen), or xanthine derivatives (e.g., theophylline); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: personal or family history of regular use/abuse of drugs/alcohol, thoughts of suicide or history of suicide attempt, aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives), severe breathing problems (e.g., respiratory depression, hypercarbia), severe stomach/bowel problems (e.g., stomach/intestinal ulcers, infectious diarrhea), bleeding/blood clotting disorders (e.g., hemophilia, von Willebrand's disease, thrombocytopenia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), heart disease (e.g., irregular heartbeat, recent heart attack), lung diseases (e.g., chronic obstructive pulmonary disease-COPD, asthma, hypoxia, hypercapnia), disease of the pancreas (e.g., pancreatitis), mental/mood disorders (e.g., toxic psychosis, depression), a certain spinal problem (kyphoscoliosis), gallbladder disease, kidney disease, liver disease, adrenal gland problem (e.g., Addison's disease), difficulty urinating (e.g., due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism), intestinal diseases (e.g., colitis), recent bowel/abdominal surgery, gout, heartburn, growths in the nose (nasal polyps), abdominal problems (e.g., colitis), anemia, high blood pressure.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain enzyme deficiencies (pyruvate kinase or G6PD deficiency).

Before having surgery tell your doctor or dentist that you are using this medication.

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 medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication contains aspirin. Children and teenagers should not take aspirin if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine, without first consulting a doctor about Reye's syndrome, a rare but serious illness.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug.

This medication is not recommended for use during pregnancy. Consult your doctor for more details.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. 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 medications because very serious interactions may occur: ketorolac, mifepristone, naltrexone.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: acetazolamide, adenosine, antacids, anticholinergic medications (e.g., scopolamine), beta agonists (e.g., albuterol), "blood thinners" (e.g., warfarin, heparin, ticlopidine), certain antibiotics (e.g., penicillin, sulfonamides such as sulfamethoxazole, macrolide antibiotics such as erythromycin), certain anti-seizure medications (e.g., carbamazepine, phenytoin, valproic acid), certain drugs used to treat gout (e.g., uricosuric drugs such as probenecid, sulfinpyrazone), cimetidine, corticosteroids (e.g., prednisone), diabetes drugs (e.g., sulfonylureas such as glyburide, insulin), disulfiram, drugs that lower blood pressure (e.g., "water pills"/diuretics such as hydrochlorothiazide/furosemide, ACE inhibitors such as lisinopril/enalapril), drugs that may affect hearing (e.g., vancomycin), ginkgo biloba, lepirudin, lithium, MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), 6-mercaptopurine, methotrexate, other medications for pain (e.g., pentazocine, nalbuphine, morphine), pemetrexed, ritonavir/tipranavir, salicylates (e.g., salsalate), certain antidepressants (SSRIs such as fluoxetine, fluvoxamine; tricyclic antidepressants such as doxepin), zidovudine.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products, other headache medications) because they may contain aspirin, caffeine, or ingredients that cause drowsiness. Also keep in mind that certain beverages (e.g., coffee, colas, tea) contain caffeine. Avoid drinking large amounts of caffeinated beverages while taking this medication because severe nervousness and irritability can occur. Ask your pharmacist about using those products safely.

Also check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as ibuprofen/naproxen) that are similar to this drug and may increase your risk for side effects if taken together with this medication.

This medication may interfere with certain medical/laboratory tests (including fasting blood glucose, cholesterol levels, prothrombin time, urine 5-HIAA levels, amylase and lipase levels, certain urine glucose tests, dipyridamole-thallium imaging tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

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. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, slow and shallow breathing, slow/irregular heartbeat, very small pupils, severe dizziness, fainting, persistent nausea/vomiting, sudden difficulty hearing, ringing in the ears, 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 another condition unless told to do so by your doctor. A different medication may be necessary in that case.

If you miss a dose, take it as soon as you remembered unless it is almost time for the next dose. In that case, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature at 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.