This medication is used to treat mild to moderate pain. It acts on certain centers in the brain and spinal cord to give you pain relief. Codeine is a narcotic pain reliever related to morphine.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Codeine may also be used to control a cough.

Take this medication by mouth as directed by your doctor. Pain medications work best when taken at the first signs of pain. If you wait until the pain has worsened, the medication may not work as well. The dosage is based on your medical condition and response to therapy. For children, the dosage is also based on weight.

For the liquid form, measure the medication with the provided dose-measuring spoon or device to make sure you have the correct dose. Do not use a household spoon. If you are extremely drowsy after using this medication, consult your doctor or pharmacist promptly. Your dosage may need to be lowered.

If so directed by your doctor, you may also use long-acting narcotic medications for ongoing pain. In that case, this medication might be used when needed for sudden attacks of "breakthrough" pain. Also follow your doctor's or pharmacist's instructions for the safe use of non-narcotic pain relievers (e.g., acetaminophen, ibuprofen). Ask your doctor or pharmacist if you have any questions about your treatment.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, runny nose, watering eyes, trouble sleeping, severe abdominal/muscle pain, nausea, vomiting, rapid breathing, and fast heartbeat) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Though it is very unlikely to occur, this medication can also be habit-forming and may result in abnormal drug-seeking behavior (addiction). Do not increase your dose, take it more frequently, or use it for a longer period of time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted.

When used for a long time, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Inform your doctor if your pain persists or worsens.

Nausea commonly occurs with the use of codeine and usually goes away after the first few doses. Consult your doctor or pharmacist about ways to decrease nausea (e.g., antihistamines, taking with food, lying down for 1-2 hours with as little head movement as possible).

Lightheadedness, dizziness, drowsiness, dry mouth, flushing, vomiting, constipation, and sweating may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/shallow breathing, mental/mood changes (e.g., agitation, confusion, restlessness), fast/slow/irregular heartbeat, fainting, vision changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), hives, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking codeine, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications (e.g., morphine, hydrocodone, oxycodone); or to sulfites (found in some brands); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, carbon dioxide retention), a certain bowel disease (paralytic ileus), severe infectious diarrhea (e.g., pseudomembranous colitis), intoxication with medications that can cause drowsiness or slow/shallow breathing (e.g., alcohol or tranquilizers/sedatives).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (e.g., gallbladder disease, pancreatitis, ulcerative colitis), adrenal gland problems (e.g., Addison's disease), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), heart problems (e.g., irregular heartbeat, low blood pressure), kidney disease, liver disease, lung diseases (e.g., chronic obstructive pulmonary disease-COPD, hypoxia, emphysema), personal or family history of regular drug/alcohol abuse, mental/mood disorders (e.g., toxic psychosis), spinal problem (kyphoscoliosis), underactive thyroid (hypothyroidism), difficulty urinating (e.g., enlarged prostate, urethral stricture).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially slow/shallow breathing, drowsiness, and difficulty urinating.

This medication should be used only when clearly needed during pregnancy. It is not recommended for use for long periods or in high doses near the expected delivery date because of the potential for harm to your unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for a long time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell your doctor immediately if your infant develops increased sleepiness, difficulty feeding, or trouble breathing. Discuss the risks and benefits with your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: narcotic antagonists (e.g., naltrexone, naloxone).

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting codeine.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergic drugs (e.g., scopolamine), other medications for pain (e.g., narcotic agonists/antagonists such as butorphanol/nalbuphine), quinidine, cimetidine.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., hydrocodone), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This medication may interfere with certain laboratory tests (including amylase and lipase tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: slow breathing, slow heartbeat, cold/clammy skin, loss of consciousness.

Do not share this medication with others. It is against the law.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in those cases.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.