Brand Names: Tylenol with Codeine, Tylenol with Codeine #2, Tylenol with Codeine #3, Tylenol with Codeine #4
Generic Name: acetaminophen and codeine
- What is acetaminophen and codeine?
- What are the possible side effects of acetaminophen and codeine?
- What is the most important information I should know about acetaminophen and codeine?
- What should I discuss with my healthcare provider before taking acetaminophen and codeine?
- How should I take acetaminophen and codeine?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while taking acetaminophen and codeine?
- What other drugs will affect acetaminophen and codeine?
- Where can I get more information?
What is acetaminophen and codeine?
Acetaminophen and codeine is a combination medicine used to relieve moderate to severe pain.
Acetaminophen and codeine may also be used for other purposes not listed in this medication guide.
What are the possible side effects of acetaminophen and codeine?
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.
Call your doctor at once if you have:
- noisy breathing, sighing, shallow breathing;
- a light-headed feeling, like you might pass out;
- confusion, severe drowsiness; or
- liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.
Common side effects include:
- drowsiness, dizziness, feeling tired;
- nausea, vomiting, stomach pain;
- constipation; or
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 codeine?
MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.
Do not give this medicine to anyone younger than 12 years old, or anyone under 18 who recently had surgery to remove the tonsils or adenoids.
An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have pain in your upper stomach, loss of appetite, dark urine, or jaundice (yellowing of your skin or eyes).
Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.
What should I discuss with my healthcare provider before taking acetaminophen and codeine?
You should not use this medicine if you are allergic to acetaminophen or codeine, or if you have:
- severe asthma or breathing problems; or
- a blockage in your stomach or intestines.
Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.
Codeine is not approved for use by anyone younger than 12 years old.
Do not give this medicine to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.
Tell your doctor if you have ever had:
- liver disease;
- alcoholism or drug addiction;
- urination problems;
- kidney disease; or
- problems with your pancreas, thyroid, or gallbladder.
If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.
Do not breast-feed. Codeine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.
How should I take acetaminophen and codeine?
Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away acetaminophen and codeine is against the law.
If you need surgery or medical tests, tell the surgeon or doctor ahead of time that you are using this medicine.
You should not stop using this medicine suddenly. Follow your doctor's instructions about tapering your dose.
Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.
What happens if I miss a dose?
Since this medicine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medicine can be fatal, especially in a child or other person using the medicine without a prescription. Overdose can cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.
What should I avoid while taking acetaminophen and codeine?
Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Do not drink alcohol. Dangerous side effects or death could occur.
Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking certain medications together can lead to a fatal overdose.
What other drugs will affect acetaminophen and codeine?
You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.
Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
- cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
- medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
- other narcotic medications--opioid pain medicine or prescription cough medicine;
- a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
- drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;
- drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.
This list is not complete. Other drugs may affect acetaminophen and codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
Where can I get more information?
Your doctor or pharmacist can provide more information about acetaminophen and codeine.
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