Tramadol is a narcotic-like pain reliever.

Acetaminophen is a less potent pain reliever that increases the effects of tramadol.

The combination of acetaminophen and tramadol is used to treat moderate to severe pain.

Acetaminophen and tramadol may also be used for purposes other than those listed in this medication guide.

Take acetaminophen and tramadol exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label.

Do not take more of this medication than is recommended. An acetaminophen and tramadol overdose can be fatal. The maximum amount of acetaminophen and tramadol is 2 tablets per dose, or 8 tablets per day.

Take this medicine with a full glass of water.

Acetaminophen and tramadol can be taken with or without food, but take it the same way each time.

Do not stop using this medication suddenly without talking to your doctor. You may need to gradually reduce the dose. Withdrawal symptoms such as anxiety, sweating, nausea, diarrhea, tremors, chills, hallucinations, trouble sleeping, or breathing problems may occur when you stop using acetaminophen and tramadol.

Call your doctor at once if you have any of these withdrawal symptoms after you stop using acetaminophen and tramadol.

Store acetaminophen and tramadol at room temperature away from moisture and heat.

Before taking acetaminophen and tramadol, tell your doctor if you also use:

• carbamazepine (Tegretol);

• warfarin (Coumadin);

• digoxin (Lanoxin, Lanoxicaps);

• ketoconazole (Nizoral);

• erythromycin (E-Mycin, E.E.S., Ery-Tab);

• rifampin (Rifadin, Rimactane, Rifater);

• St. John’s wort;

• quinidine (Quinaglute, Quinadex, Cardioquin, Quinora); or

• an antidepressant such as amitriptyline (Elavil), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor); paroxetine (Paxil), or sertraline (Zoloft).

If you are using any of these drugs, you may not be able to use acetaminophen and tramadol or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect acetaminophen and tramadol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Do not drink alcohol while you are taking acetaminophen and tramadol. Alcohol may cause a dangerous decrease in your breathing when used together with acetaminophen and tramadol.

Avoid using drugs that make you sleepy (such as cold medicine, other pain medications, muscle relaxants, and medicine for seizures, depression or anxiety). These drugs may slow your breathing or increase drowsiness when used together with acetaminophen and tramadol.

Acetaminophen and tramadol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not use any other over-the-counter cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen is contained in many cold and pain medicines available over the counter. If you take certain products together you may accidentally take too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen.

Seek emergency medical attention if you think you have used too much of this medicine. A acetaminophen and tramadol overdose can be fatal.

Symptoms of a acetaminophen and tramadol overdose may include drowsiness, shallow breathing, slow heartbeat, extreme weakness, cold or clammy skin, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes, feeling light-headed, fainting, or coma.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Do not take more of this medication than is recommended. An acetaminophen and tramadol overdose can be fatal. The maximum amount of acetaminophen and tramadol is 2 tablets per dose, or 8 tablets per day.

Do not use any other over-the-counter cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen is contained in many cold and pain medicines available over the counter. If you take certain products together you may accidentally take too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

Seizures (convulsions) have occurred in some people taking acetaminophen and tramadol. You may be more likely to have a seizure while taking acetaminophen and tramadol if you have a history of seizures or head injury, a metabolic disorder, a brain or spinal cord infection, or if you are taking certain medicines. Talk with your doctor about your individual risk of having a seizure from this medicine.

While you are taking acetaminophen and tramadol, do not drink alcohol or use drugs that make you sleepy (such as cold medicine, other pain medications, muscle relaxants, and medicine for seizures, depression or anxiety). These drugs may slow your breathing or increase drowsiness when used together with acetaminophen and tramadol.

Acetaminophen and tramadol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not take this medication if you are allergic to acetaminophen and tramadol, if you are intoxicated (drunk), or if you have recently used any of the following drugs:

• alcohol;

• narcotic pain medicine;

• sedatives or tranquilizers (such as Valium);

• medicine for depression or anxiety;

• medicine for mental illness (such as bipolar disorder, schizophrenia); or

• street drugs.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

Seizures have occurred in some people taking acetaminophen and tramadol. Your risk of a seizure may be higher if you have any of these conditions:

• a history of drug or alcohol addiction;

• a history of epilepsy or other seizure disorder;

• a history of head injury;

• a metabolic disorder;

• an infection of your brain or spinal cord, such as meningitis or encephalitis;

• if you are also taking an antidepressant, mood stabilizer, or another narcotic pain medicine; or

• if you have taken an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

Talk with your doctor about your individual risk of having a seizure from this medicine.

Before taking acetaminophen and tramadol, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;

• liver disease;

• asthma or other breathing disorder;

• a stomach disorder; or

• a history of depression, mental illness, or suicide attempt.

If you have any of these conditions, you may not be able to use acetaminophen and tramadol, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Acetaminophen and tramadol may also cause serious or fatal side effects in a newborn if the mother uses the medication during pregnancy or labor. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Acetaminophen and tramadol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medicine to a child younger than 16 years of age.

Your pharmacist has more information about acetaminophen and tramadol written for health professionals that you may read.

Acetaminophen and acetaminophen and tramadol is available with a prescription under the brand name Ultracet. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Ultracet 325 mg/37.5 mg—yellow, capsule-shaped, film-coated tablets.