TALWIN Nx (pentazocine and naloxone hydrochlorides, USP) contains pentazocine hydrochloride, USP, equivalent to 50 mg base and is a member of the benzazocine series (also known as the benzomorphan series), and naloxone hydrochloride, USP, equivalent to 0.5 mg base.

TALWIN Nx is an analgesic for oral administration.

Chemically, pentazocine hydrochloride is (2R*,6R*,11R*)-1,2, 3, 4, 5, 6­Hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol hydrochloride, a white, crystalline substance soluble in acidic aqueous solutions, and has the following structural formula:

C₁₉H₂₇NO·HCl........................M.W. 321.88

Chemically, naloxone hydrochloride is Morphinan-6-one, 4, 5-epoxy-3, 14­dihydroxy-17-(2-propenyl)-, hydrochloride, (5α)-. It is a slightly off-white powder, and is soluble in water and dilute acids, and has the following structural formula:

C₁₉H₂₁NO₄·HCl..................M.W.=363.84

Inactive Ingredients: Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, D&C Yellow #10, FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Sodium Lauryl Sulfate, Starch.

Last updated on RxList: 10/24/2008

TALWIN Nx (pentazocine and naloxone hydrochlorides, USP) is indicated for the relief of moderate to severe pain.

TALWIN Nx is indicated for oral use only.

Adults

The usual initial adult dose is 1 tablet every three or four hours. This may be increased to 2 tablets when needed. Total daily dosage should not exceed 12 tablets.

When anti-inflammatory or antipyretic effects are desired in addition to analgesia, aspirin can be administered concomitantly with this product.

Pediatric Patients

Since clinical experience in pediatric patients under 12 years of age is limited, administration of this product in this age group is not recommended.

Duration of Therapy

Patients with chronic pain who receive TALWIN Nx orally for prolonged periods have only rarely been reported to experience withdrawal symptoms when administration was abruptly discontinued (see WARNINGS). Tolerance to the analgesic effect of pentazocine has also been reported only rarely. However, there is no long-term experience with the oral administration of TALWIN Nx.

Talwin Nx (pentazocine and naloxone hydrochlorides, USP) is available as yellow, scored, oblong tablets, debossed with a "W" surrounded by a box on one side and "T51" on the other. Each tablet containspentazocine hydrochloride equivalent to 50 mg base and naloxone hydrochloride equivalent to 0.5 mg base.

Bottles of 100 (NDC 0024-1951-04).

Store at 25° C (77° F); excursions permitted between 15° - 30° C (59° F to 86° F).

Manufactured for: Sanofi-Aventis U.S. LLC Bridgewater, NJ 08807. Revised November 2007. FDA Rev date: 9/1/2008

Last updated on RxList: 10/24/2008

Cardiovascular

Hypertension, hypotension, circulatory depression, tachycardia, syncope. Respiratory. Rarely, respiratory depression.

Acute CNS Manifestations

Patients receiving therapeutic doses of pentazocine have experienced hallucinations (usually visual), disorientation, and confusion which have cleared spontaneously within a period of hours. The mechanism of this reaction is not known. Such patients should be closely observed and vital signs checked. If the drug is reinstituted it should be done with caution since these acute CNS manifestations may recur.

Other CNS Effects

Grand mal convulsions, increase in intracranial pressure, dizziness, lightheadedness, hallucinations, sedation, euphoria, headache, confusion, disorientation; infrequently weakness, disturbed dreams, insomnia, syncope, visual blurring and focusing difficulty, depression; and rarely tremor, irritability, excitement, tinnitus.

Autonomic

Sweating; infrequently flushing; and rarely chills.

Gastrointestinal

Nausea, vomiting, constipation, diarrhea, anorexia, dry mouth, biliary tract spasm, and rarely abdominal distress.

Allergic

Edema of the face; anaphylactic shock; dermatitis, including pruritus; flushed skin, including plethora; infrequently rash, and rarely urticaria.

Ophthalmic

Visual blurring and focusing difficulty, miosis.

Hematologic

Depression of white blood cells (especially granulocytes), with rare cases of agranulocytosis, which is usually reversible, moderate transient eosinophilia.

Dependence and Withdrawal Symptoms. (See WARNINGS, PRECAUTIONS, and Drug Abuse And Dependence Sections).

Other

Headache, chills, insomnia, weakness, urinary retention, paresthesia, serious skin reactions, including erythema multiforme, Stevens-Johnson syndrome toxic epidermal necrolysis, and alterations in rate or strength of uterine contractions during labor.

Drug Abuse And Dependence

Controlled Substance

TALWIN Nx is a Schedule IV controlled substance. Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of a drug for non-medical purposes, often in combination with other psychoactive substances. Addiction is a disease of repeated drug abuse. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. Addiction is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common. Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects lerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of addiction and is characterized by misuse of the drug for non-medical purposes, and often in combination with other psychoactive substances.

There have been some reports of dependence and of withdrawal symptoms with orally administered pentazocine. Patients with a history of drug dependence should be under close supervision while receiving pentazocine orally. There have been rare reports of possible abstinence syndromes in newborns after prolonged use of pentazocine during pregnancy.

There have been reports of development of addiction and physical dependence in patients receiving parenteral pentazocine. People with a history of drug abuse or alcohol abuse may have a higher chance of becoming addicted to opioid medicines.

Abrupt dose cessation or rapid dose reduction following the extended use of parenteral pentazocine has resulted in withdrawal symptoms such as abdominal cramps, nausea, vomiting, elevated temperature, chills, rhinorrhea, restlessness, anxiety, or lacrimation. In general opioid therapy should not be abruptly discontinued. When the patient no longer requires treatment with Talwin Nx, the drug should be tapered gradually to prevent signs and symptoms of withdrawal in patients who have been receiving opioids for an extended period of time and might have become physically dependent.

In prescribing pentazocine for chronic use, the physician should take under consideration that proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to identify and decrease misuse and abuse of opioid drugs.

The amount of naloxone present in TALWIN Nx (0.5 mg per tablet) has no action when taken orally and will not interfere with the pharmacologic action of pentazocine. However, this amount of naloxone given by injection has profound antagonistic action to narcotic analgesics.

Severe, even lethal, consequences may result from misuse of tablets by injection either alone or in combination with other substances, such as pulmonary emboli, vascular occlusion, ulceration and abscesses, and withdrawal symptoms in narcotic dependent individuals.

TALWIN Nx contains an opioid antagonist, naloxone (0.5 mg). Naloxone is inactive when administered orally at this dose, and its inclusion in TALWIN Nx is intended to curb a form of misuse of oral pentazocine. Parenterally, naloxone is an active narcotic antagonist. Thus, TALWIN Nx has a lower potential for parenteral misuse than the previous oral pentazocine formulation TALWIN® 50 (pentazocine hydrochloride tablets, USP). However, it is still subject to patient misuse and abuse by the oral route.

Concomitant use of monoamine oxidase inhibitors (MAOIs) with pentazocine may cause CNS excitation and hypertension through their respective effects on catecholamines. Caution should therefore be observed in administering pentazocine to patients who are currently receiving MAOIs or who have received them within the preceding 14 days.

Agents with CNS depressant properties including phenothiazine, tricyclic antidepressants, and ethyl alcohol can enhance the central nervous system depressant effects of pentazocine (See WARNINGS).

Tobacco smoking could enhance the metabolic clearance rate of pentazocine reducing the clinical effectiveness of a standard dose of pentazocine.

Pentazocine can antagonize the effects of opiate agonists such as diamorphine, morphine, and heroin and is itself antagonized by naloxone.

Last updated on RxList: 10/24/2008

Drug Dependence

Pentazocine can cause a physical and psychological dependence. (See Drug Abuse And Dependence)

Head Injury and Increased Intracranial Pressure

As in the case of other potent analgesics, the potential of pentazocine for elevating cerebrospinal fluid pressure may be attributed to CO₂ retention due to the respiratory depressant effects of the drug. These effects may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a preexisting increase in intracranial pressure. Furthermore, pentazocine can produce effects which may obscure the clinical course of patients with head injuries. In such patients, pentazocine must be used with extreme caution and only if its use is deemed essential.

Usage with Alcohol

Due to the potential for increased CNS depressants effects, alcohol should be used with caution in patients who are currently receiving pentazocine.

Patients Receiving Narcotics

Pentazocine is a mild narcotic antagonist. Some patients previously given narcotics, including methadone for the daily treatment of narcotic dependence, have experienced withdrawal symptoms after receiving pentazocine.

Certain Respiratory Conditions

Although respiratory depression has rarely been reported after oral administration of pentazocine, the drug should be administered with caution to patients with respiratory depression from any cause, severely limited respiratory reserve, severe bronchial asthma, and other obstructive respiratory conditions, or cyanosis.

Acute CNS Manifestations

Patients receiving therapeutic doses of pentazocine have experienced hallucinations (usually visual), disorientation, and confusion which have cleared spontaneously within a period of hours. The mechanism of this reaction is not known. Such patients should be very closely observed and vital signs checked. If the drug is reinstituted, it should be done with caution since these acute CNS manifestations may recur.

CNS Effect

Caution should be used when pentazocine is administered to patients prone to seizures; seizures have occurred in a few such patients in association with the use of pentazocine though no cause and effect relationship has been established.

Porphyria

Particular caution should be exercised in administering pentazocine to patients with porphyria since it may provoke an acute attack in susceptible individuals.

Cardiovascular Disease

Pentazocine can elevate blood pressure, possibly through the release of endogenous catecholamines. Particular caution should be exercised in conditions where alterations in vascular resistance and blood pressure might be particularly undesirable, such as in the acute phase of myocardial infarction.

As with all drugs, pentazocine should be used with caution in patients with myocardial infarction who have nausea or vomiting.

Impaired Renal or Hepatic Function

Decreased metabolism of pentazocine by the liver in extensive liver disease may predispose to accentuation of side effects. Although laboratory tests have not indicated that pentazocine causes or increases renal or hepatic impairment, the drug should be administered with caution to patients with such impairment.

In prescribing pentazocine for long-term use, the physician should take precautions to avoid increases in dose by the patient.

Other

Caution should also be observed when administering pentazocine in patients with hypothyroidism, adrenocortical insufficiency, prostate hypertrophy, inflammatory or obstructive bowel disease, acute abdominal syndromes of unknown etiology, cholecystitis, pancreatitis, or acute alcohol intoxication and delirium tremens.

Biliary Surgery

Narcotic drug products are generally considered to elevate biliary tract pressure for varying periods following their administration. Some evidence suggests that pentazocine may differ from other marketed narcotics in this respect (i.e., it causes little or no elevation in biliary tract pressures). The clinical significance of these findings, however, is not yet known.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals to test for carcinogenesis have been performed with the components of TALWIN Nx.

Pregnancy Category C

In animal reproduction studies (rodents), teratogenic effects were reported only at doses high enough to cause maternal toxicity. The safe use of pentazocine in pregnant women (other than during labor) has not been established. TALWIN Nx should be given to pregnant women only if clearly needed.

Labor and Delivery

Patients receiving pentazocine during labor have experienced no adverse effects other than those that occur with commonly used analgesics. However, pentazocine can cross the placental barrier and cause central nervous system depression in the newborn and, if used regularly throughout pregnancy, may lead to symptoms of withdrawal in the newborn. TALWIN Nx should be used with caution in women delivering premature infants. The effect of TALWIN Nx on the mother and fetus, the duration of labor or delivery, the possibility that forceps delivery or other intervention or resuscitation of the newborn may be necessary, or the effect of TALWIN Nx on the later growth, development, and functional maturation of the child are unknown at the present time.

Nursing Mothers

Pentazocine is excreted in human milk. Caution should be exercised when TALWIN Nx is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Geriatric Use

Controlled clinical studies of TALWIN NX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses or effectiveness in analgesic activity between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Last updated on RxList: 10/24/2008

Manifestations

The symptoms and clinical signs of pentazocine overdosage may resemble those of morphine or other opioids. They may include somnolence, respiratory depression, hypotension, hypertension, tachycardia, hallucinations, or seizures. Circulatory failure and deepening coma may occur in more severe cases, particularly in patients who have also ingested other CNS depressants such as alcohol, sedative/hypnotics, or antihistamines.

Treatment

Adequate measures to maintain ventilation and general circulatory support should be employed. Assisted or controlled ventilation, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Consideration should be given to gastric lavage and gastric aspiration. For respiratory depression due to overdosage or unusual sensitivity to pentazocine, parenteral naloxone is a specific and effective antagonist. Initial doses of 0.4 to 2.0 mg of naloxone are recommended, repeated at 2-3 minute intervals, if needed, up to a total of 10 mg. Anti­convulsant therapy may be necessary.

TALWIN Nx should not be administered to patients who are hypersensitive to either pentazocine or naloxone.

Last updated on RxList: 10/24/2008

Pentazocine is a potent analgesic which when administered orally in a 50 mg dose appears equivalent in analgesic effect to 60 mg (1 grain) of codeine. Onset of significant analgesia usually occurs between 15 and 30 minutes after oral administration, and duration of action is usually three hours or longer. Onset and duration of action and the degree of pain relief are related both to dose and the severity of pretreatment pain. Pentazocine weakly antagonizes the analgesic effects of morphine and meperidine; in addition, it produces incomplete reversal of cardiovascular, respiratory, and behavioral depression induced by morphine and meperidine. Pentazocine has about 1/50 the antagonistic activity of nalorphine. It also has sedative activity.

Pentazocine is well absorbed from the gastrointestinal tract. Concentrations in plasma coincide closely with the onset, duration, and intensity of analgesia; peak values occur 1 to 3 hours after oral administration. The half-life in plasma is 2 to 3 hours.

Pentazocine is metabolized in the liver and excreted primarily in the urine. Pentazocine passes into the fetal circulation. Naloxone when administered orally at 0.5 mg has no pharmacologic activity.

Naloxone hydrochloride administered parenterally at the same dose is an effective antagonist to pentazocine and a pure antagonist to narcotic analgesics.

TALWIN Nx is a potent analgesic when administered orally. However, the presence of naloxone in TALWIN Nx will prevent the effect of pentazocine if the product is misused by injection.

Studies in animals indicate that the presence of naloxone does not affect pentazocine analgesia when the combination is given orally. If the combination is given by injection the action of pentazocine is neutralized.

Last updated on RxList: 10/24/2008

Since sedation, dizziness, and occasional euphoria have been noted, ambulatory patients should be warned not to operate machinery, drive cars, or unnecessarily expose themselves to hazards. Pentazocine may cause physical and psychological dependence when taken alone and may have additive CNS depressant properties when taken in combination with alcohol or other CNS depressants.

Last updated on RxList: 10/24/2008

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.

PENTAZOCINE/NALOXONE - ORAL

(pen-TAZZ-oh-seen/nal-OX-own)

COMMON BRAND NAME(S): Talwin NX

USES: This product is used to treat moderate to severe pain. It contains 2 medications, pentazocine and naloxone. Pentazocine is a narcotic pain reliever (opiate-type). It acts on certain centers in the brain to give you pain relief. Naloxone helps to prevent misuse of this product. It blocks the effect of pentazocine and may cause withdrawal reactions if this product is dissolved and injected. Naloxone does not have any effect when taken by mouth.

HOW TO USE: Take this medication by mouth with or without food, usually every 3 to 4 hours or as directed by your doctor. If you have nausea, it may help to take this drug with food. Consult your doctor or pharmacist about other ways to decrease nausea (such as taking antihistamines, lying down for 1 to 2 hours with as little head movement as possible).

The dosage is based on your medical condition and response to treatment. Do not take more than 600 milligrams of pentazocine in a 24-hour period. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

Pain medications work best if they are used when the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

If you have been regularly using other narcotic pain medications (for example, morphine, methadone), withdrawal reactions (such as restlessness, watery eyes, widened pupils, sweating, runny nose) may occur when you start this product. Consult with your doctor or pharmacist for more details.

This medication may cause dependence, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal reactions (such as restlessness, watery eyes, widened pupils, sweating, runny nose) may occur if you suddenly stop this drug. 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.

When this medication is used for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your pain persists or worsens.

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, increased sweating, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a 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: fainting, mental/mood changes (such as agitation, hallucinations, confusion), difficulty urinating, vision changes, fast heartbeat.

Tell your doctor immediately if these rare but very serious side effects occur: slow/shallow breathing, severe stomach/abdominal pain, change in the amount of urine, signs of infection (such as fever, persistent sore throat), seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), 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 this product, tell your doctor or pharmacist if you are allergic to pentazocine or naloxone; 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: certain bowel diseases (paralytic ileus, infectious diarrhea).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung disease (such as asthma, chronic obstructive pulmonary disease-COPD), a certain spinal problem (kyphoscoliosis), breathing problems (such as slow/shallow breathing, sleep apnea), certain heart problems (irregular heartbeat), personal or family history of regular use/abuse of drugs/alcohol, brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), underactive thyroid (hypothyroidism), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), disease of the pancreas (such as pancreatitis), mental/mood disorders (such as toxic psychosis), gallbladder disease, adrenal gland problem (such as Addison's disease), intestinal disorders (such as colitis, blockage).

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Limit 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 lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Older adults may be more sensitive to the effects of this drug, especially slow/shallow breathing and drowsiness.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used 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.

It is unknown if this product passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use section.

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

This drug should not be used with the following medications because very serious interactions may occur: naltrexone, sibutramine.

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

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: fluoxetine, MAO inhibitors (for example, furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine).

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, anti-seizure drugs (such as phenobarbital), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and psychiatric medicines (such as risperidone, amitriptyline, trazodone). Your medications or their doses may need to be changed.

Check the labels on all your medicines (such as cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

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. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, severe drowsiness, severe dizziness, pinpoint pupils.

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 that case.

MISSED DOSE: If you take this product regularly and 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.