EZ III

Generic Name: acetaminophen and codeine (a SEET a MIN o fen and KOE deen)Brand Names: Capital with Codeine Suspension, Cocet, EZ III, Tylenol with Codeine #3, Tylenol with Codeine #4, Vopac

What is EZ III (acetaminophen and 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.

What is the most important information I should know about EZ III (acetaminophen and codeine)?

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.

An overdose of acetaminophen can damage your liver. Adults should not take more than 1 gram (1000 mg) of acetaminophen per dose or 4 grams (4000 mg) per day. If you drink more than three alcoholic beverages per day, you should never use more than 2 grams (2000 mg) of acetaminophen per day. Ask a doctor or pharmacist before using any cold, allergy, pain, or sleep medicine. Acetaminophen (sometimes abbreviated as "APAP") is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen. Check the label to see if a medicine contains acetaminophen or APAP. Codeine may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Acetaminophen and codeine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.What should I discuss with my healthcare provider before taking EZ III (acetaminophen and codeine)?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. Never share acetaminophen and codine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

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.

If you have any of these other conditions, you may need a dose adjustment or special tests:

• 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.

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. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. 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.

How should I take EZ III (acetaminophen and codeine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

An overdose of acetaminophen can damage your liver. Adults should not take more than 1 gram (1000 mg) of acetaminophen per dose or 4 grams (4000 mg) per day. If you drink more than three alcoholic beverages per day, you should never use more than 2 grams (2000 mg) of acetaminophen per day.

One acetaminophen and codeine tablet may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Take this medicine with food or milk to ease stomach upset.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and codeine. Do not use a stool softener (laxative) without first asking your doctor. Do not stop using acetaminophen and codeine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using acetaminophen and codeine.

This medication can cause unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen and codeine.

If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and codeine. You may need to stop using the medicine for a short time.

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 medication 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. 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 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.

What should I avoid while taking EZ III (acetaminophen and codeine)?

Acetaminophen and codeine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be 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. It may increase your risk of liver damage.

EZ III (acetaminophen and codeine) 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.

What other drugs will affect EZ III (acetaminophen and codeine)?

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 other drugs may interact with acetaminophen and codeine. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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.
• 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 1996-2006 Cerner Multum, Inc. Version: 7.01. Revision Date: 01/27/2010 12:05:12 PM.