Ingredient Name: TRAMADOL (TRA-ma-doll) and ACETAMINOPHEN (a-seat-a-MIN-oh-fen)

Drug Manufacturer: MCNEIL

Common Uses: This medicine is an analgesic combination used to treat or prevent pain for a short period of time (usually 5 days or less).

Before Using This Medicine: 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 carbamazepine, cyclobenzaprine, an amphetamine, opiate analgesic, tricyclic antidepressant, serotonin reuptake inhibitor (SSRI), monoamine oxidase inhibitor (MAOI), promethazine, or medicine for appetite suppression, sleep, or a nervous, mood, or behavior condition. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITIONS may be needed if you are taking isoniazid, quinidine, or an oral anticoagulant (e.g., warfarin). Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have liver disease or high levels of alcohol, depressants, stimulants, or other analgesics in your blood. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. THIS MEDICINE MAY BE TAKEN on an empty stomach or with food. 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 you remember. 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 A SEVERE ALLERGIC REACTION to codeine, hydrocodone, dihydrocodeine, or oxycodone (such as Tylox, Tylenol with Codeine, Vicodin). A severe allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness. If you have a question about whether you are allergic to this medicine, or if a certain medicine contains any of these medicines, contact you doctor or pharmacist. IF YOU EXPERIENCE difficulty breathing; tightness of chest; swelling of eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more doses of this medicine unless your doctor tells you to do so. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. If using this medicine for an extended period of time, DO NOT SUDDENLY STOP taking this medicine without your doctor's approval. Your dose may need to be lowered slowly to avoid side effects. AVOID ALCOHOL while you are using this medicine. THIS MEDICINE WILL ADD TO THE EFFECTS of alcohol and other depressants. Ask your pharmacist if you have any 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. If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take this medicine or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Alcohol use combined with this medicine 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. IF DIZZINESS OCCURS, sit or stand up slowly. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. Caution is advised when using this medicine in the elderly because they may be more sensitive to the effects of this 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. DO NOT BREAST-FEED while taking this medicine.

Possible Side Effects: SIDE EFFECTS that may occur while taking this medicine include drowsiness, dizziness, or constipation. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you develop a skin rash, itching, confusion, changes in mood or behavior, dark urine or pale stools, yellowing of the skin or eyes, or unusual tiredness. CONTACT YOUR DOCTOR IMMEDIATELY if you experience seizures or halluncinations. 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, 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 nausea, vomiting, sweating, unusual drowsiness, slowed breathing, seizures, stomach pain, dark urine, deep sleep or loss of consciousness, coma, and death.

Additional Information: IF YOUR SYMPTOMS DO NOT IMPROVE or if they become worse, check with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children.