Tylenol with Codeine (acetaminophen / codeine), also known as Tylenol #3, is a combination opioid medication. Both acetaminophen and codeine treat mild-to-moderate pain by blocking pain signals in the body. This medication is taken by mouth, typically every 4 hours as needed. Tylenol with Codeine is available as a tablet and liquid. Like other opioids, Tylenol with Codeine can cause common side effects like sleepiness, dizziness, and constipation. It also has a warning for dangerous breathing problems and risk of dependence and misuse.
Treatment of mild-to-moderate pain that isn't relieved by non-opioid pain medications alone
Tylenol with Codeine is a combination of two medications that work together to treat pain.
Codeine is an opioid receptor agonist. It's broken down into morphine in your body and it binds to certain opioid receptors in your brain to lower how much pain you feel.
Acetaminophen is an analgesic. It stops the production of certain chemicals in your brain, which can help relieve pain.
Tylenol with Codeine can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: History of alcohol or substance misuse | Taking more Tylenol with Codeine than prescribed | Suddenly stopping Tylenol with Codeine
Even at recommended doses, taking Tylenol with Codeine can put a person at risk for addiction, abuse, or misuse. Taking Tylenol with Codeine for reasons other than prescribed (misuse) or at higher doses than prescribed can lead to overdose and death. Your healthcare professional (HCP) will prescribe the lowest amount of Tylenol with Codeine that's necessary for the shortest period of time possible.
The FDA requires a Risk Evaluation and Mitigation Strategies (REMS) program for this medication because of its potential for dependence and misuse. Under the REMS program, your HCP will go over how to use Tylenol with Codeine safely, its risks, and proper storage and disposal to help keep you and your loved ones safe. If you have concerns about taking Tylenol with Codeine, talk to your HCP about alternative pain medications.
Risk factors: Older adult | Children younger than 12 years old | Taking medications that can cause slow breathing | Drinking alcohol | Medical conditions that cause breathing problems | Taking higher doses of Tylenol with Codeine | Ultra-rapid metabolizers of Tylenol with Codeine | Breastfed babies from mothers taking Tylenol with Codeine
Tylenol with Codeine can cause dangerously slow breathing, which can be life-threatening. This can happen at any time, but you're at higher risk 1 to 3 days right after you start Tylenol with Codeine or right after your HCP raises your dose. Drinking alcohol and taking other medications, like benzodiazepines, can also raise your risk for this dangerous side effect. You're recommended to ask your prescriber about getting naloxone (Narcan) before you start Tylenol with Codeine so that you can have it available in case of an accidental overdose. If you or your loved one notice you have trouble breathing or have bluish-colored lips, fingers, or toes, call 911 to get medical help right away.
Risk factors: History of opioid use disorder | Previous opioid overdose | Taking high doses of Tylenol with Codeine | Taking more opioids than prescribed | Alcohol use | Age 65 years or older
Take Tylenol with Codeine exactly as prescribed. Taking too much Tylenol with Codeine or taking it more often than prescribed can lead to an overdose. If you're taking the liquid version of this medication, make sure to use a medication dosing cup or oral syringe to measure out your dose. Don't use a household spoon because the dose might not be accurate and you might accidentally take too much medication. Be sure you and your loved ones know how to recognize symptoms of an overdose, such as not responding to sound or touch, extremely slowed breathing, extreme sleepiness, slow heartbeat, and cold or clammy skin.
Your HCP will likely prescribe naloxone (Narcan) for you to have on hand in case of an accidental opioid overdose. Make sure you carry naloxone (Narcan) with you at all times in case you experience an overdose. Call 911 right away if this happens.
Store Tylenol with Codeine out of reach from children, pets, or visitors. If you don't need to take Tylenol with Codeine anymore, throw away the medication through a take-back program.
If you take Tylenol with Codeine during pregnancy, you can pass the medication to your unborn baby. Long-term use during pregnancy can cause your unborn baby to become dependent on opioids. Once your baby is born, they can experience withdrawal symptoms, such as high-pitched crying, poor feeding and sucking behavior, trembling, irritability, abnormal sleep patterns, and seizures. This condition is called neonatal opioid withdrawal syndrome and can be life-threatening if not recognized and treated in time. Let your healthcare provider know if you've used Tylenol with Codeine during pregnancy or if you notice these symptoms in your baby.
Tylenol with Codeine can interact with many medications. For example, taking certain medications, like erythromycin (Ery-tab) and ritonavir (Norvir), can raise the level of codeine and put you at higher risk for breathing problems. And starting certain medications, like rifampin (Rifadin) or carbamazepine (Tegretol), while you're already taking Tylenol with Codeine might lower the level of codeine and put you at risk for withdrawal symptoms.
Before starting Tylenol with Codeine, make sure your care team is aware of all the medications you're currently taking. Don't start or stop any medications without first checking with your care team.
Risk factors: Taking higher doses of Tylenol with Codeine | Age 65 years or older | Drinking alcohol | Taking other medications that can cause sleepiness
Tylenol with Codeine can cause extreme sleepiness and lower your ability to think, react, and focus. Your risk is higher if you're taking other medications that can make you sleepy, such as benzodiazepines, muscle relaxants, and sleep medications. Make sure you know how this medication affects you before driving a car or doing activities that require your concentration. Talk to your HCP right away if you feel too sleepy from taking Tylenol with Codeine.
Risk factors: Drinking alcohol | Taking other medications containing acetaminophen | Taking higher than recommended dose of acetaminophen | Liver problems
Taking too much acetaminophen can cause liver damage that can be permanent and life-threatening. For adults, the maximum amount of acetaminophen is 3,000 mg or 4,000 mg, depending on your health condition, in a 24-hour period, depending on your prescriber's instructions. For children, ask your child's pediatrician.
Speak to your provider before using Tylenol with Codeine if you have liver problems, since it can cause further damage to your liver. Also avoid drinking alcohol while taking Tylenol with Codeine, since this combination can harm your liver too.
Signs of liver problems include dark urine, feeling tired, upset stomach or stomach pain, or yellowing of the skin or whites of the eyes. If you notice any of these symptoms, call your HCP right away.
Risk factors: Allergy to other opioids | Sulfite allergy
Severe allergic reactions to Tylenol with Codeine are possible, including life-threatening reactions like facial swelling, shock, and anaphylaxis (e.g., closing of the throat). If you notice hives, rash, red skin, swelling of the lips or tongue, or difficulty breathing after taking Tylenol with Codeine, get medical attention right away.
Additionally, although rare, acetaminophen can cause serious skin reactions, such as rash, blisters, skin reddening, or skin peeling. If you notice changes in your skin, stop using Tylenol with Codeine and get medical attention right away.
Risk factors: History of seizure conditions
Opioids can cause people with a history of seizures to have seizures more often. Tylenol with Codeine can also raise your risk of seizures in certain situations. Let your HCP know if you have seizures more often while taking Tylenol with Codeine.
Tylenol with Codeine can cause extremely low blood pressure, including a drop in blood pressure when you stand from a sitting or lying down position. This can lead to dizziness and fainting. To avoid falling, get up slowly if you've been sitting or lying down. If dizziness or lightheadedness doesn't go away, talk to your HCP.
Risk factors: Taking Tylenol with Codeine for longer than 1 month
Though rare, opioids like Tylenol with Codeine can cause your adrenal hormone levels to drop. This is more likely to happen after taking opioids for longer than 1 month. Symptoms include nausea, vomiting, not feeling hungry, tiredness, dizziness, and weakness. Let your provider know right away if you experience these symptoms because you might need to stop Tylenol with Codeine and be treated with corticosteroids.
People with certain medical conditions shouldn't take Tylenol with Codeine.
For example, this medication can't be taken by people with certain stomach-related conditions, such as slow movement of the gut. The codeine in this medication can worsen gut movement.
Tylenol with Codeine isn't appropriate for people with head injuries, brain tumors, or other brain-related medical conditions. This is because this medication can slow breathing and lower oxygen levels in the brain, which can be dangerous.
Before starting Tylenol with Codeine, make sure to let your medical team know about what medical conditions you have so that they can check to see if this medication is safe for you to take.
If you have been taking Tylenol with Codeine every day for an extended period of time, don't suddenly stop taking this medication without talking with your HCP. Stopping this medication too suddenly can lead to opioid withdrawal, which includes symptoms such as anxiety, nausea, diarrhea, and stomach pain
Source: DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Difficult or trouble breathing
irregular, fast or slow, or shallow breathing
pale or blue lips, fingernails, or skin
Incidence not known
Black, tarry stools
bleeding gums
blood in the urine or stools
difficulty with swallowing
dizziness
fast heartbeat
fever with or without chills
general feeling of tiredness or weakness
hoarseness
lower back or side pain
painful or difficult urination
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
sores, ulcers, or white spots on the lips or in the mouth
tightness in the chest
unusual bleeding or bruising
unusual tiredness or weakness
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
Bloody or cloudy urine
chills
constricted, pinpoint, or small pupils (black part of the eye)
dark urine
headache
increased sweating
light-colored stools
loss of appetite
loss of consciousness
seizures
stomach pain
sudden decrease in the amount of urine
unpleasant breath odor
vomiting
vomiting of blood
yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Drowsiness
lightheadedness
relaxed and calm feeling
sleepiness
Incidence not known
Difficulty having a bowel movement
false or unusual sense of well-being
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Works well for treating mild-to-moderate pain
Combines 2 medications with different modes of pain relief into a single pill
Available in a liquid form for people who have trouble swallowing tablets
Available as a generic medication
For short-term pain relief only
Can be habit-forming
Not recommended to take with other medications containing acetaminophen, since it can raise the risk of liver damage
Liquid solution contains alcohol
You can take Tylenol with Codeine with or without food. If it's upsetting your stomach, try taking it with food to help.
Avoid drinking alcohol while taking opioid-containing medications, like Tylenol with Codeine. Drinking alcohol can worsen certain side effects of Tylenol with Codeine, such as sleepiness and dizziness. It can also harm your ability to think or react, as well as raise your risk for dangerously slow breathing.
If you've been taking Tylenol with Codeine regularly for a period of time and want to stop, talk with your provider first. They might need to lower your dose slowly over time before you can stop completely. This is to help you avoid withdrawal symptoms, such as anxiety, sweating, chills, and irritability.
Since Tylenol with Codeine already contains acetaminophen (Tylenol), don't take other medications that also contain acetaminophen (Tylenol). The maximum daily dose of acetaminophen is 4,000 mg for most people. But if you have certain health conditions, such as liver problems, your recommended maximum dose per day might be even lower.
If you're taking the liquid form, store the medication at room temperature. Make sure to only use a medication dose cup or syringe from the pharmacy to measure out your dose. Don't use household spoons because they aren't accurate and might cause you to take too much Tylenol with Codeine.
Ask your pain specialist about getting naloxone (Narcan). This is a medication that's used to help reverse the effects of Tylenol with Codeine during an accidental overdose. You're recommended to have this medication with you, as a precaution.
Let your prescriber know if you're pregnant before you start taking Tylenol with Codeine or if you become pregnant while you're taking this medication. Tylenol with Codeine isn't recommended during pregnancy.
Tell your healthcare team if you're breastfeeding. It's typically recommended to avoid Tylenol with Codeine because the opioid medication can get into breast milk. This raises the risk for serious side effects to your baby (e.g., sleepiness, slowed breathing).
Keep Tylenol with Codeine out of reach from children, pets, or visitors. There are a few drug take-back options to get rid of the medication safely if you don't need to take it anymore. This lessens the risk for accidental overdose and medication misuse.
Your healthcare professional (HCP) will prescribe the lowest dose of Tylenol with Codeine for the shortest duration of time to treat your pain.
Tylenol with Codeine tablets
Adults: The typical starting dose is 300 mg/15 mg (Tylenol with Codeine) by mouth every 4 hours as needed for pain.
Tylenol with Codeine oral solution
Each 5 mL contains 12 mg of codeine and 120 mg of acetaminophen.
Adults: The typical dose is 15 mL by mouth every 4 hours as needed.
Don't take more than 4,000 mg of acetaminophen within a 24-hour period.
Tylenol with Codeine shouldn't be given to children younger than 12 years of age, or to children younger than 18 years of age if they recently had tonsil or adenoid surgery.
GoodRx has partnered with PatientsLikeMe to provide reviews on the different aspects of Tylenol with Codeine.
Learn more about the effectiveness of Tylenol with Codeine based on real life experiences.
Based on 52 people taking this medication
3.2
3.2
3.3
3.8
2.5
3.1
Severity of side effects
Based on 182 people taking this medication
0%
50%
100%
Constipation
14%
Sleepiness
5%
Nausea
5%
Upset stomach
3%
Headaches
3%
Reasons people stopped taking Tylenol with Codeine
Based on 188 people who have taken this medication
Did not seem to work
25%
Doctor's advice
20%
Course of treatment ended
19%
Side effects too severe
18%
Other
16%
Personal research
3%
Change in health plan coverage
2%
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Children younger than 12 years of age
Children younger than 18 years of age for pain management after tonsil or adenoid surgery
Severely slowed breathing (respiratory depression)
Severe asthma
Conditions that cause blockage of the stomach passageway
Allergy to codeine or another opioid
Allergy to acetaminophen (Tylenol)
Current or recent (within 14 days) use of a monoamine oxidase inhibitor MAOIs
Treatment of mild-to-moderate pain that isn't relieved by non-opioid pain medications alone
Toothache
Backache
Muscle aches
Minor arthritis pain
Ankylosing spondylitis (AS) (arthritis of the spine)
Polyarticular juvenile idiopathic arthritis (arthritis in children)
Tendonitis and bursitis
Pain
By signing up, I agree to GoodRx's Terms and Privacy Policy, and to receive marketing messages from GoodRx.
Centers for Disease Control and Prevention. (2022). About opioid use during pregnancy.
Department of Justice, Drug Enforcement Administration. (2020). Narcotics.
Drugs and Lactation Database (LactMed®). (2023). Codeine.
Food and Drug Administration. (2023). Opioid analgesic Risk Evaluation and Mitigation Strategy (REMS).
Food and Drug Administration. (2022). Drug disposal: Drug take back locations.
Food and Drug Administration. (2016). FDA drug safety communication: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen.
Food and Drug Administration. (2015). Determination that TYLENOL WITH CODEINE (acetaminophen with codeine phosphate) oral tablets, 325 milligrams/7.5 milligrams, 325 milligrams/15 milligrams, 325 milligrams/30 milligrams, and 325 milligrams/60 milligrams, were not withdrawn from sale for reasons of safety or effectiveness. Federal Register.
Genus Lifesciences Inc. (2023). ACETAMINOPHEN AND CODEINE PHOSPHATE solution [package insert]. DailyMed.
Gerriets, V., et al. (2022). Acetaminophen. StatPearls.
Jansson, L. M., et al. (2020). Neonatal abstinence syndrome. Pediatric Clinics of North America.
National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Adrenal insufficiency & Addison’s disease.
National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Symptoms & causes of adrenal insufficiency & Addison’s Disease.
Opioid Analgesics REMS Program Companies. (n.d.). Risk evaluation and mitigation strategy (REMS).
SpecGx LLC. (2023). ACETAMINOPHEN AND CODEINE PHOSPHATE tablet [package insert]. DailyMed.
Takahashi, P. Y., et al. (2017). Increased risk of hospitalization for ultrarapid metabolizers of cytochrome P450 2D6. Pharmacogenomics and Personalized Medicine.
U.S. Department of Health and Human Services. (n.d.). Preventing an opioid overdose.
Research prescriptions and over-the-counter medications from A to Z, compare drug prices, and start saving.