Acetaminophen and Codeine

Important warning:

The combination of acetaminophen and codeine may be habit forming. Take acetaminophen and codeine exactly as directed. Do not take more or less of it, take it more often, stop taking it suddenly, or take it in a different way than directed by your doctor. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness.

The combination of acetaminophen and codeine may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased.If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Taking too much acetaminophen (as found in this combination preparation) can cause liver damage, sometimes serious enough to require liver transplantation or cause death. Do not take more than 4,000 mg of acetaminophen per day. If you need to take more than one product that contains acetaminophen, calculate the total amount of acetaminophen you are taking. Ask your doctor or pharmacist to help you.

Acetaminophen and codeine may harm or cause death to other people who take your medication, especially children. Store acetaminophen and codeine in a safe place so that no one else can take it accidentally or on purpose.

Taking certain medications, drinking alcohol, or using street drugs during your treatment with acetaminophen and codeine may increase the risk that you will experience breathing problems or other serious, life-threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the dosages of your medications and will monitor you carefully.

Tell your doctor if you are pregnant or plan to become pregnant. If you take acetaminophen and codeine regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with acetaminophen and codeine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of taking acetaminophen and codeine.

Why is this medicine prescribed?

The combination of acetaminophen and codeine is used to relieve pain. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers).It works by changing the way the body senses pain and by cooling the body.Codeine belongs to a class of medications called opiate (narcotic) analgesics.When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

The combination of acetaminophen and codeine comes as a tablet, capsule, and liquid to take by mouth.Take every 4 hours as needed.

Your doctor may adjust your dose during your treatment, depending on how well your pain is controlled and on the side effects that you experience. Talk to your doctor about how you are feeling during your treatment with acetaminophen and codeine. Tell your doctor if you feel that your pain is not controlled or if your pain increases, becomes worse, or if you have new pain or an increased sensitivity to pain during your treatment with acetaminophen and codeine. Do not take more of it or take it more often than prescribed by your doctor.

Talk to your doctor or pharmacist about access to rescue medicines, naloxone or nalmefene,while taking acetaminophen and codeine. Rescue medications can reverse the life-threatening effects of anopioid overdose and are available over the counter or with a prescription. Make sure that youand your family members and people usually around you know how to recognize an overdose,how to use naloxone or nalmefene, and what to do until emergency medical help arrives. Yourdoctor or pharmacist will show you and others how to use it. If symptoms of an overdose occur,they should give the first dose of naloxone, call 911 immediately, and stay with you and watchyou closely until emergency medical help arrives. If your symptoms return, the person shouldgive you another dose of the rescue medication. Additional doses may be given every 2 to 3minutes, if symptoms return before medical help arrives.

If you have taken acetaminophen and codeine for several weeks or longer, do not stop taking the medication without talking to your doctor. Your doctor may decrease your dose gradually. If you suddenly stop taking acetaminophen and codeine, you may experience withdrawal symptoms such as restlessness, widened pupils (black circles in the center of the eyes), teary eyes, irritability, anxiety, runny nose, difficulty falling asleep or staying asleep, yawning, sweating, fast breathing, fast heartbeat, chills, nausea, loss of appetite, vomiting, diarrhea, stomach cramps, or muscle aches.

If you are taking acetaminophen and codeine oral solution, do not use a household spoon to measure your dose. Use the measuring cup or spoon that came with the medication or use a spoon that is made especially for measuring medication. Ask your pharmacist if you have any question about how much medication you should take or how to use the dosing cup or syringe.

What special precautions should I follow?

Before taking acetaminophen and codeine,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• some medications should not be taken with acetaminophen and codeine. Make sure you have discussed anymedications you are currently taking or plan to take before starting acetaminophen and codeine with your doctorand pharmacist. Before starting, stopping, or changing any medications while taking acetaminophen and codeine,please get the advice of your doctor or pharmacist.

• Tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, or tranylcypromine.

• the following nonprescription products may interact with acetaminophen and codeine: St. John's wort and tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking acetaminophen and codeine. Do not start any of these medications while taking acetaminophen and codeine without discussing with your healthcare provider.

• tell your doctor if you have slowed breathing, asthma, chronic pulmonary disease (COPD), or other lung problems; a blockage or narrowing of your stomach or intestines, or paralytic ileus (condition in which digested food does not move through the intestines).Your doctor may tell you not to take acetaminophen and codeine if you have any of these conditions.

• tell your doctor if you have or have ever had a brain tumor, or any condition that increases the amount of pressure in your brain; seizures, or pancreas, gallbladder, or heart, liver, or kidney disease.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking acetaminophen and codeine.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If youbecome pregnant while taking acetaminophen and codeine, call your doctor.

• you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

• you should know to not drink alcoholic beverages while you are taking acetaminophen and codeine. Alcohol can make the side effects from acetaminophen and codeine worse.

• you should know that acetaminophen and codeine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• you should know that acetaminophen and codeine may cause constipation. Talk to your doctor about changing your diet and using other medications to treat or prevent constipation.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

This medication usually is taken as needed. If your doctor has told you to take acetaminophen and codeine regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medicine cause?

Acetaminophen and codeine may cause side effects. Tell your doctor if any of these symptoms or those in the SPECIAL PRECAUTIONS section are severe or do not go away:

• nausea, vomiting
• sweating
• decreased sexual desire, inability to get or keep an erection

Some side effects can be serious. If you experience any of these symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical help:

• nausea, vomiting, loss of appetite, weakness, or dizziness
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• rash; hives; itching; red, peeling or blistering skin; difficulty breathing or swallowing; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• chest pain, changes in heartbeat
• seizures
• extreme drowsiness
• new pain or pain from touch or doing ordinary tasks such as combing your hair
• difficulty swallowing, regurgitation (bringing up swallowed food into throat and mouth), pain in the chest area
• unusual snoring or long pauses during breaths during sleep

Acetaminophen and codeine may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

If someone takes more than the recommended dose of acetaminophen and codeine, get medical help immediately, even if the person does not have any symptoms. Symptoms of overdose may include the following:

• nausea, vomiting
• loss of appetite
• sweating
• unusual bleeding or bruising
• pain in upper right part of the stomach
• yellowing of skin or eyes
• slow or shallow breathing, difficulty breathing
• unable to respond or wake up
• loss of muscle tone
• increase or decrease in pupil (dark circle in the eye) size
• cold and clammy skin
• slow heartbeat

What other information should I know?

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking acetaminophen and codeine.

Do not let anyone else take your medication. Acetaminophen and codeine is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

Brand name(s)

• Capital^® & Codeine¶
• Codrix^®¶
• Empracet^® (#3, #4) ¶
• Papa-deine^® (#3, #4) ¶
• Phenaphen^® with Codeine (#2, #3, #4) ¶
• Proval^® #3¶
• Tylenol^® with Codeine (#3, #4)
• Fioricet^® with Codeine (as a combination product containing Acetaminophen, Butalbital, Caffeine, Codeine)
• Phrenilin^® with Caffeine, Codeine (as a combination product containing Acetaminophen, Butalbital, Caffeine, Codeine)¶
• also available generically

Other name(s)

• APAP and Codeine (as a combination product containing Acetaminophen and Codeine)

^¶ This branded product is no longer on the market. Generic alternatives may be available.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2025.