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acetaminophen and codeine

Pronunciation

Generic Name: acetaminophen and codeine (a SEET a MIN o fen and KOE deen)
Brand Name: Tylenol with Codeine #3, Tylenol with Codeine #4, ...show all 10 brand names

What is acetaminophen and codeine?

Codeine is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of 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 is the most important information I should know about acetaminophen and codeine?

MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

You should not use this medicine if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

This medicine is not for use in children younger than 12 years old, and is not for use in anyone under 18 who recently had surgery to remove the tonsils or adenoids.

Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

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 recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

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.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

Acetaminophen and codeine should not be given to a child 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.

Do not breast-feed while taking acetaminophen and codeine. This medicine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

To make sure this medicine is safe for you, tell your doctor if you have ever had :

  • liver disease, cirrhosis, or if you drink alcohol;

  • alcoholism or drug addiction;

  • diarrhea, inflammatory bowel disease, bowel obstruction;

  • kidney disease;

  • a head injury, brain tumor, or stroke;

  • asthma, sleep apnea, or other breathing disorders; or

  • if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

If you use this 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 habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

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.

Codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. 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.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using acetaminophen and codeine.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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 symptoms may include extreme drowsiness, pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while taking acetaminophen and codeine?

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Do not drink alcohol. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Acetaminophen and codeine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, codeine can slow your breathing. Death may occur if breathing becomes too weak.

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.

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.

Call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing;

  • a slow heart rate or weak pulse;

  • a light-headed feeling, like you might pass out;

  • confusion, unusual thoughts or behavior;

  • seizure (convulsions);

  • missed menstrual periods, impotence, sexual problems;

  • easy bruising or bleeding;

  • liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or

  • high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

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;

  • upset stomach, constipation;

  • blurred vision; or

  • dry mouth.

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.

Acetaminophen and codeine dosing information

Usual Adult Dose for Pain:

Initial dose: Acetaminophen (300 to 600 mg) and codeine (15 to 60 mg) orally every 4 hours as needed for pain
-Titrate to a dose that provides adequate analgesia and minimizes adverse reactions
Maximum doses: Acetaminophen 4000 mg/24 hours; Codeine: 360 mg/24 hours

Comments:
-Initial doses should be individualized taking into account severity of pain, response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
-Codeine doses higher than 60 mg have not been shown to improve pain relief and are associated with an increased incidence of adverse effects; tolerance to codeine can develop with continued use.
-Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

Use: For the management of mild to moderate pain where treatment with an opioid is appropriate and from which alternative treatments are inadequate.

Usual Pediatric Dose for Pain:

Less than 12 years: Contraindicated

12 to 18 years (postoperatively following a tonsillectomy and/or adenoidectomy): Contraindicated

12 to 18 years (with risk factors for respiratory depression): Avoid use

12 to 18 years: Use only if benefits outweigh potential risks
-Initial dose: Acetaminophen (300 to 600 mg) and codeine (15 to 60 mg) orally every 4 hours as needed for pain
Maximum doses: Acetaminophen 4000 mg/24 hours; Codeine: 360 mg/24 hours

Comments:
-Risk factors that increase sensitivity to the respiratory depressant effects of codeine include postoperative status, obstructive sleep apnea, obesity, and other conditions associated with hypoventilation syndromes (e.g., neuromuscular disease), concomitant use of other mediations that cause respiratory depression, and severe pulmonary disease.
-Initial doses should be individualized taking into account severity of pain, response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
-Codeine doses higher than 60 mg have not been shown to improve pain relief and are associated with an increased incidence of adverse effects.
-Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

Use: For the management of mild to moderate pain where treatment with an opioid is appropriate and from which alternative treatments are inadequate.

What other drugs will affect acetaminophen and codeine?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • other narcotic medications--opioid pain medicine or prescription cough medicine;

  • drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

  • drugs that affect serotonin levels in your body--medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with acetaminophen and codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

See also: Side effects (in more detail)

Where can I get more information?

  • Your pharmacist can provide more information about acetaminophen and codeine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 14.02.

Last reviewed: May 25, 2017
Date modified: October 13, 2017

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