Tramadol Hydrochloride, Acetaminophen Oral tablet
What is this medicine?
ACETAMINOPHEN; TRAMADOL (a set a MEE noe fen; TRA ma dole) is a pain reliever. It is used to treat short term moderate pain.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
drug abuse or addiction
if you often drink alcohol
kidney disease or trouble passing urine
lung disease, asthma, or breathing problems
seizures or epilepsy
suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
an unusual or allergic reaction to acetaminophen, tramadol, codeine, other opioid analgesics, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
How should I use this medicine?
Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. If the medicine upsets your stomach, take it with food or milk. Do not take more than you are told to take.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
What may interact with this medicine?
alcohol or medicines that contain alcohol
carbamazepine or oxcarbazepine
medicines for depression, anxiety, or psychotic disturbances
medicines for pain including pentazocine, buprenorphine, butorphanol, nalbuphine, tramadol, and propoxyphene
medicines for sleep
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Tell your doctor or health care professional if your pain does not go away, if it gets worse, or if you have new or a different type of pain.
You may get drowsy or dizzy when you first start taking the medicine or change doses. Do not drive, use machinery, or do anything that may be dangerous until you know how the medicine affects you. Stand or sit up slowly.
Too much acetaminophen can be very dangerous. Do not take Tylenol (acetaminophen) or medicines that contain acetaminophen with this medicine. Many non-prescription medicines contain acetaminophen. Always read the labels carefully.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
feeling faint or lightheaded, falls
redness, blistering, peeling or loosening of the skin, including inside the mouth
yellowing of the eyes or skin
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children. Tramadol is a morphine-like drug that can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and is against the law.
This medicine may cause accidental overdose and death if it taken by other adults, children, or pets. Mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F).
NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
March 21, 2017
U.S. FDA-approved Package Insert