What is acetaminophen-codeine?

Codeine is in a group of drugs called narcotic pain relievers. Acetaminophen is a less potent pain reliever that increases the effects of codeine.

The combination of acetaminophen and codeine is used to relieve moderate to severe pain.

Acetaminophen and codeine may also be used for other purposes not listed in this medication guide.

Precautions

Do not use this medication if you are allergic to acetaminophen (Tylenol) or codeine.

Codeine may be habit-forming and should be used only by the person it was prescribed for. Acetaminophen and codeine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Before using acetaminophen and codeine, tell your doctor if you are allergic to any drugs, or if you have:

  • asthma, COPD, sleep apnea, or other breathing disorders;
  • liver or kidney disease;
  • a history of head injury or brain tumor;
  • epilepsy or other seizure disorder;
  • low blood pressure;
  • a stomach or intestinal disorder;
  • underactive thyroid;
  • Addison's disease or other adrenal gland disorder;
  • enlarged prostate, urination problems;
  • curvature of the spine;
  • mental illness; or
  • a history of drug or alcohol addiction.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Before you take acetaminophen and codeine, tell your doctor if you are pregnant or plan to become pregnant during treatment.

Acetaminophen and codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP”) is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP.

Avoid drinking alcohol while taking acetaminophen and codeine. Alcohol may increase your risk of liver damage while taking acetaminophen.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of acetaminophen and codeine can be fatal.

Overdose symptoms may include extreme drowsiness, sweating, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, cold and clammy skin, fainting, weak pulse, seizure (convulsions), coma, blue lips, shallow breathing, or no breathing.

Since acetaminophen and codeine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

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Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • feeling light-headed, fainting;
  • confusion, unusual thoughts or behavior;
  • seizure (convulsions);
  • easy bruising or bleeding; or
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

  • feeling dizzy or drowsy;
  • mild nausea, vomiting, upset stomach, constipation;
  • headache;
  • 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. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

Before taking acetaminophen and codeine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, other pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by codeine.

Also tell your doctor if you are using any of the following drugs:

  • glycopyrrolate (Robinul);
  • mepenzolate (Cantil);
  • atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
  • a bronchodilator such as ipratroprium (Atrovent) or tiotropium (Spiriva); or
  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and there may be other drugs that can interact with acetaminophen and codeine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Other Names

Capital with Codeine Suspension, EZ III, Phenaphen with Codeine, Tylenol with Codeine, Tylenol with Codeine #2, Tylenol with Codeine #3, Vopac, acetaminophen-codeine, codeine-acetaminophen, and Tylenol with Codeine #4

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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 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04

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