Each tablet for oral administration contains: Codeine Sulfate 15,30, or 60 mg (WARNING: May be habit forming.) Chemically, Codeine Sulfate is, Morphinan-6-ol ,7,8-didehydro-4,5-epoxy- 3-methoxy-17-methyl-(5a ,6a )-, sulfate (2:1) (salt), trihydrate.

Codeine Sulfate acts as a narcotic analgesic.

Inactive Ingredients: Thetablets contain colloidal silicon dioxide, microcrystalline cellulose, starch, sodium starch glycolate, and stearic acid.

For the relief of mild to moderate pain.

Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of narcotics. Codeine tablets are given orally. The usual adult dose is 15 to 60 mg every 4 hours as needed.

15 mg white scored tablets (Identified 54 613).

NDC 0054-8155-24: Unit dose, 25 tablets per card, (reverse numbered), 4 cards per shipper.

30 mg white scored tablets (Identified 54 783).

NDC 0054-8156-24: Unit dose, 25 tablets per card, (reverse numbered), 4 cards per shipper. NDC 0054-4156-25: Bottles of 100 tablets.

60 mg white scored tablets (Identified 54 412).

NDC 0054-8157-24: Unit dose, 25 tablets per card, (reverse numbered), 4 cards per shipper. NDC 0054-4157-25: Bottles of 100 tablets.

DEA Order Form Required. Caution: Federal law prohibits dispensing without prescription.

THE MAJOR HAZARDS OF CODEINE, AS OF OTHER NARCOTIC ANALGESICS, ARE RESPIRATORY DEPRESSION AND, TO A LESSER DEGREE, CIRCULATORY DEPRESSION. RESPIRATORY ARREST, SHOCK, AND CARDIAC ARREST HAVE OCCURRED.

The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. These effects seem to be more prominent in ambulatory patients and in those who are not suffering severe pain. In such individuals, lower doses are advisable. Some adverse reactions may be alleviated in the ambulatory patient if he lies down.

Other adverse reactions include the following:

Central Nervous System — Euphoria, dysphoria, weakness, headache, insomnia, agitation, disorientation, and visual disturbances.

Gastrointestinal — Dr. mouth, anorexia, constipation, and biliary tract spasm.

Cardiovascular — Flushing of the face, bradycardia, palpitation, faintness, and syncope.

Genitourinary— Urinary retention or hesitancy, anti- diuretic effect, and reduced libido and/or potency.

Allergic— Pruritus, urticaria, other skin rashes, edema, and, rarely, hemorrhagic urticaria.

Drug Dependence

Codeine Sulfate can produce drug dependence of the morphine type, and therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of this drug and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic-containing medications. Like other narcotic-containing medications, the drug is subject to the Federal Controlled Substances Act.

Usage in Ambulatory Patients

Codeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.

Interaction with Other Central Nervous System Depressants

Patients receiving other narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with codeine may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

Usage in Pregnancy

Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore codeine should not be used in pregnant women unless, in the judgment of the physician, the potential benefits outweigh the possible hazards.

Pediatric Use

Safe dosage of this drug has not been established in children below the age of three.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre- existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of codeine or other narcotics may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

Special Risk Patients

Codeine should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepaticorrenalfunction, hypothyroidism, Addison's disease, and prostatic hypertrophy or urethral stricture.

Signs and Symptoms

Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

Treatment: Primary attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including codeine. Therefore, an appropriate dose of naloxone (usual initial adult dose: 0.4 mg) should be administered, preferably by the intravenous route and simultaneously with efforts at respiratory resuscitation. Since the duration of action of codeine may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration.

An antagonist should not be administeredin the absence of clinically significant respiratory or cardiovascular depression.

Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.

Gastric emptying may be useful in removing unabsorbed drug.

Hypersensitivity to codeine.

The major effects of codeine are on the central nervous system and the bowel. Opioids act as agonists, interacting with stereospecific and saturable binding sites or receptors in the brain and other tissues.

Codeine is readily absorbed from the gastrointestinal tract with the maximum analgesic effect occurring 60 minutes post administration. Codeine retains at least one half its analgesic activity when administered orally.

See WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

CODEINE - ORAL

(KOE-deen)

USES: 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.

HOW TO USE: 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 dependence, especially if it is used regularly for a long period of time or if it is used in high doses. In such cases, if you suddenly stop this drug, withdrawal reactions may occur. Such reactions can include restlessness, runny nose, watering eyes, trouble sleeping, severe abdominal/muscle pain, nausea, vomiting, rapid breathing, and fast heartbeat. Report any such reactions to your doctor immediately. When stopping long-term, regular treatment with this drug, gradually reducing the dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details.

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.

SIDE EFFECTS: 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, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: 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. Use caution while engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages because they may increase the risk of this drug's side effects.

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. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

DRUG INTERACTIONS: 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.

OVERDOSE: 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.

NOTES: 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.

MISSED DOSE: 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.

STORAGE: 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 2008 Copyright(c) 2008 First DataBank, Inc.