Brand Names: Ultracet

Generic Name: acetaminophen and tramadol (Pronunciation: a SEET a MIN o fen and TRAM a dol)

• What is acetaminophen and tramadol (Ultracet)?
• What are the possible side effects of acetaminophen and tramadol (Ultracet)?
• What is the most important information I should know about acetaminophen and tramadol (Ultracet)?
• What should I discuss with my healthcare provider before taking acetaminophen and tramadol (Ultracet)?
• How should I take acetaminophen and tramadol (Ultracet)?
• What happens if I miss a dose (Ultracet)?
• What happens if I overdose (Ultracet)?
• What should I avoid while taking acetaminophen and tramadol (Ultracet)?
• What other drugs will affect acetaminophen and tramadol (Ultracet)?
• Where can I get more information?

What is acetaminophen and tramadol (Ultracet)?

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 other purposes not listed in this medication guide.

Acetaminophen-Tramadol 325 mg-37.5 mg-IVA

oblong, yellow, imprinted with 650, O M

Acetaminophen-Tramadol 325 mg-37.5 mg-PAR

oblong, orange, imprinted with 083, KALI

APAP-Tramadol 37.5-325 mg-CAR

oblong, yellow, imprinted with 537

Ultracet

oblong, yellow, imprinted with O-M, 650

What are the possible side effects of acetaminophen and tramadol (Ultracet)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using acetaminophen and tramadol and call your doctor at once if you have any of these serious side effects:

• seizure (convulsions);
• a red, blistering, peeling skin rash; or
• shallow breathing, weak pulse.

Less serious side effects may include:

• dizziness, drowsiness, weakness;
• nausea, vomiting, constipation, loss of appetite;
• blurred vision;
• flushing (redness, warmth, or tingly feeling); or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about acetaminophen and tramadol (Ultracet)?

You should not take this medication if you are allergic to acetaminophen and tramadol, if you are intoxicated (drunk), or if you have recently used narcotic pain medicine, a sedative or tranquilizer, medicine for depression or mental illness, or any type of street drug.

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.

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.

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.