When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use if you had an allergic reaction to acetaminophen, tramadol, or other narcotic pain medicines.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine is not for long-term use.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• This combination medicine contains acetaminophen. Carefully check the labels of all other medicines you are using because they may also contain acetaminophen. It is not safe to take more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).
• Some foods and medicines can affect how tramadol/acetaminophen works. Tell your doctor if you are using St John's wort, carbamazepine, cyclobenzaprine, digoxin, lithium, promethazine, an MAO inhibitor, medicine for depression, medicine for migraine headaches, or a blood thinner (such as warfarin).
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.
• Do not drink alcohol while you are using this medicine. Acetaminophen can damage your liver, and alcohol can increase this risk.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, kidney disease, breathing problems, depression, or mental illness. Tell your doctor if you have a history of head injury or seizures, or if you have been addicted to drugs or alcohol.
• This medicine may cause the following problems:
  
  • Liver damage
  • High risk of overdose
  • Serotonin syndrome
• This medicine may make you drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, or red skin rash
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Extreme dizziness, drowsiness, or weakness, trouble breathing, slow heartbeat or breathing, seizures, and cold, clammy skin
• Seizures
• Trouble breathing

If you notice these less serious side effects, talk with your doctor:

• Constipation

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088