Acetaminophen and Codeine (2023)

This information from Lexicomp^® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: US

Tylenol with Codeine #3 [DSC]; Tylenol with Codeine #4 [DSC]

Brand Names: Canada

Acet Codeine 60 [DSC]; PMS-Acetaminophen/Codeine; Procet-30 [DSC]; TEVA-Emtec-30; TEVA-Lenoltec No 4; Triatec-30; Tylenol #4 [DSC]

Warning

All products:

• This drug is a strong pain drug that can put your child at risk for addiction, abuse, and misuse. Misuse or abuse of this drug can lead to overdose and death. Talk with your child’s doctor.
• This drug may cause very bad and sometimes deadly breathing problems. Call the doctor right away if your child has slow, shallow, or trouble breathing.
• The chance of very bad and sometimes deadly breathing problems may be greater when your child first starts this drug or anytime the dose is raised. Talk with your child’s doctor.
• Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.
• This drug has acetaminophen in it. Liver problems have happened with the use of acetaminophen. Sometimes, this has led to a liver transplant or death. Most of the time, liver problems happened in people taking too much acetaminophen in a day. People were also often taking more than 1 drug that had acetaminophen in it. If you have questions, talk with your child’s doctor.
• This drug has an opioid drug in it. Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana or other forms of cannabis, or prescription or OTC drugs that may cause drowsiness or slowed actions. This includes slow or troubled breathing and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. Benzodiazepines may be used to treat many health problems like anxiety, trouble sleeping, or seizures. If you have questions, talk with the doctor.
• Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your child’s doctor and pharmacist to make sure it is safe to give this drug with all of your child’s drugs.
• Be sure your child does not drink alcohol or use products that have alcohol. Unsafe and sometimes deadly effects may happen.
• Get medical help right away if your child does not respond, answer, or react like normal; feels very sleepy or dizzy; passes out; or will not wake up.
• Do not give to a child younger than 12 years of age. Children between 12 and 18 years of age who are very overweight or have certain other health problems like sleep apnea or other lung or breathing problems must not use this drug. If your child has been given this drug, ask the doctor for information about the benefits and risks.
• Some children have had very bad and sometimes deadly breathing problems when using codeine after surgery to remove tonsils or adenoids. Do not give to a child younger than 18 years of age who has had surgery to remove tonsils or adenoids. Talk with your child’s doctor.

If your child is pregnant:

• Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. This can be life-threatening. Talk with the doctor.

Liquid (solution):

• Be sure that you know how to measure your child’s dose. Dosing errors can lead to accidental overdose and death. If you have any questions, talk with your child’s doctor or pharmacist.

What is this drug used for?

• It is used to ease pain.

What do I need to tell the doctor BEFORE my child takes this drug?

• If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
• If your child has any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood, or stomach or bowel block or narrowing.
• If your child is taking any of these drugs: Buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine.
• If your child has taken certain drugs for depression or certain other health problems in the last 14 days. This includes isocarboxazid, phenelzine, or tranylcypromine. Very high blood pressure may happen.
• If you have been told by your child’s doctor that your child is a rapid metabolizer of some drugs.

If your child is breast-feeding a baby:

• Be sure your child does not breast-feed a baby while taking this drug.

This is not a list of all drugs or health problems that interact with this drug.

Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe to give this drug with all of your child’s other drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

• Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
• Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
• To lower the chance of feeling dizzy or passing out, have your child rise slowly if your child has been sitting or lying down. Have your child be careful going up and down stairs.
• If your child has been taking this drug for a long time or at high doses, it may not work as well and your child may need higher doses to get the same effect. This is known as tolerance. Call the doctor if this drug stops working well. Do not give more than ordered.
• Long-term or regular use of opioid drugs like this drug may lead to dependence. Lowering the dose or stopping this drug all of a sudden may cause a greater risk of withdrawal or other severe problems. Talk to your child’s doctor before you lower the dose or stop giving this drug. You will need to follow the doctor’s instructions. Tell your child’s doctor if your child has more pain, mood changes, thoughts of suicide, or any other bad effects.
• If your child is allergic to sulfites, talk with your child’s doctor. Some products have sulfites in them.
• Avoid giving your child other products that have acetaminophen in them. Check labels closely. Too much acetaminophen may cause liver problems.
• Follow the directions exactly. Do not give your child more acetaminophen in a day than directed. If you do not know how much acetaminophen you can give to your child in a day, ask your child’s doctor or pharmacist. Call your child’s doctor right away if you have given your child too much acetaminophen in a day, even if your child feels well.
• This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
• Do not give this drug with other strong pain drugs or pain patches without talking to your child’s doctor first.
• Long-term use of an opioid drug may lead to lower sex hormone levels. Call your child’s doctor if your child has a lowered interest in sex, fertility problems, no menstrual period, or ejaculation problems.
• This drug may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to the doctor to see if your child has a greater chance of seizures while taking this drug.
• The chance of very bad side effects may be higher in children. This may be more likely to happen in children who have breathing problems. Deadly breathing problems have happened with the use of codeine in some children. Talk with the doctor.

If your child is pregnant:

• This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Rarely, some allergic reactions have been life-threatening.
• Signs of liver problems like dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• Feeling confused.
• Severe constipation or stomach pain. These may be signs of a severe bowel problem.
• Not able to pass urine or change in how much urine is passed.
• Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak.
• Mood changes.
• Trouble breathing, slow breathing, or shallow breathing.
• Noisy breathing.
• Breathing problems during sleep (sleep apnea).
• Change in eyesight.
• Seizures.
• A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause severe health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
• A severe and sometimes deadly problem called serotonin syndrome may happen if your child takes this drug with certain other drugs. Call your child’s doctor right away if your child has agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache.
• Taking an opioid pain drug like this drug may lead to a rare but severe adrenal gland problem. Call the doctor right away if your child feels very tired or weak, passes out, or has severe dizziness, very upset stomach, throwing up, or decreased appetite.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Constipation.
• Stomach pain.
• Upset stomach or throwing up.
• Dry mouth.
• Sweating a lot.
• Headache.
• Flushing.

These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

All products:

• Give this drug with or without food. Give with food if it causes an upset stomach.
• Have your child drink lots of noncaffeine liquids every day unless told to drink less liquid by your child’s doctor.

Liquid (solution):

• Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
• Do not use a household teaspoon or tablespoon to measure this drug. Doing so could lead to the dose being too high.

What do I do if my child misses a dose?

• If your child takes this drug on a regular basis, give a missed dose as soon as you think about it.
• If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
• Do not give 2 doses at the same time or extra doses.
• Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.

How do I store and/or throw out this drug?

• Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.
• Store this drug in a safe place where children cannot see or reach it, and where other people cannot get to it. A locked box or area may help keep this drug safe. Keep all drugs away from pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

• If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
• Do not share your child’s drug with others and do not give anyone else’s drug to your child.
• Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
• A drug called naloxone can be used to help treat an overdose of this drug. Your child’s doctor may order naloxone for you to keep while your child takes this drug. If you have questions about how to get or use naloxone, talk with your child’s doctor or pharmacist. If you think there has been an overdose, call your poison control center or get medical care right away even if naloxone has been used. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider’s examination and assessment of a patient’s specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/know/clinical-effectiveness-terms.

Last Reviewed Date

2020-07-30

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