TALACEN is a combination of pentazocine hydrochloride, USP, equivalent to 25 mg base and acetaminophen, USP, 650 mg.

Pentazocine is a member of the benzazocine series (also known as the benzomorphan series). Chemically, pentazocine is (2R*, 6R*, 11R*)1,2,3,4,5,6-hexahydro-6,11-dimethyl-3-(3-methyl-2-butenyl)-2,6-methano-3-benzazocin-8-ol, a white, crystalline substance soluble in acidic aqueous solutions, and has the following structural formula:

Chemically, acetaminophen is Acetamide, N-(4-hydroxyphenyl)-, and has the following structural formula:

Pentazocine is an analgesic and acetaminophen is an analgesic and antipyretic.

Inactive Ingredients: Colloidal Silicon Dioxide, FD&C Blue #1, Gelatin, Microcrystalline Cellulose, Potassium Sorbate, Pregelatinized Starch, Sodium Lauryl Sulfate, Sodium Metabisulfite, Sodium Starch Glycolate, Stearic Acid.

Last updated on RxList: 9/19/2008

TALACEN is indicated for the relief of mild to moderate pain.

Adult

The usual adult dose is 1 caplet every 4 hours as needed for pain relief, up to a maximum of 6 caplets per day.

The usual duration of therapy is dependent upon the condition being treated but in any case should be reviewed regularly by the physician. The effect of meals on the rate and extent of bioavailability of both pentazocine and acetaminophen has not been documented.

Talacen is available for oral administration as a pale blue, scored caplet embossed with “Winthrop” on one side and “T37” on the other side.

Bottles of 100 (NDC 0024-1937-04).

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

Revised May 2008. Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807. FDA revision date: 8/7/2008

Last updated on RxList: 9/19/2008

Clinical experience with TALACEN has been insufficient to define all possible adverse reactions with this combination. However, reactions reported after oral administration of pentazocine hydrochloride in 50 mg dosage include gastrointestinal: nausea, vomiting, infrequently constipation; and rarely abdominal distress, anorexia, diarrhea. CNS effects: 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. Allergic: infrequently rash; and rarely urticaria, edema of the face. Cardiovascular: infrequently decrease in blood pressure, tachycardia. Hematologic: rarely depression of white blood cells (especially granulocytes), which is usually reversible, moderate transient eosinophilia. Other: rarely respiratory depression, urinary retention, paresthesia, serious skin reactions, including erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis, and in one instance, an apparent anaphylactic reaction has been reported.

Numerous clinical studies have shown that acetaminophen, when taken in recommended doses, is relatively free of adverse effects in most age groups, even in the presence of a variety of disease states.

A few cases of hypersensitivity to acetaminophen have been reported, as manifested by skin rashes, thrombocytopenic purpura, rarely hemolytic anemia and agranulocytosis. Occasional individuals respond to ordinary doses with nausea and vomiting and diarrhea.

Drug Abuse And Dependence

Controlled Substance

TALACEN is a Schedule IV controlled substance.

Abuse and Dependence

There have been some reports of dependence and of withdrawal symptoms with orally administered pentazocine. There have been recorded instances of psychological and physical dependence in patients using parenteral pentazocine. Abrupt discontinuance following the extended use of parenteral pentazocine has resulted in withdrawal symptoms. Patients with a history of drug dependence should be under close supervision while receiving TALACEN. There have been rare reports of possible abstinence syndromes in newborns after prolonged use of pentazocine during pregnancy.

Some tolerance to the analgesic and subjective effects of pentazocine develops with frequent and repeated use.

Drug addicts who are given closely spaced doses of pentazocine (e.g., 60 mg to 90 mg every 4 hours) develop physical dependence which is demonstrated by abrupt withdrawal or by administration of naloxone. The withdrawal symptoms exhibited after chronic doses of more than 500 mg of pentazocine per day have similar characteristics, but to a lesser degree, of opioid withdrawal and may be associated with drug seeking behavior.

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.

Last updated on RxList: 9/19/2008

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

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 CO}2 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, TALACEN must be used with extreme caution and only if its use is deemed essential.

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.

There have been instances of psychological and physical dependence on parenteral pentazocine in patients with a history of drug abuse, and rarely, in patients without such a history. (See Drug Abuse And Dependence.)

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

Pentazocine may precipitate opioid abstinence symptoms in patients receiving courses of opiates for pain relief.

In prescribing TALACEN for chronic use, the physician should take precautions to avoid increases in dose by the patient.

Myocardial Infarction

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

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.

Impaired Renal or Hepatic Function

Decreased metabolism of the drug 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.

Since acetaminophen is metabolized by the liver, the question of the safety of its use in the presence of liver disease should be considered.

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.

CNS Effect

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis, mutagenesis, and impairment of fertility studies have not been done with this combination product.

Pentazocine, when administered orally or parenterally, had no adverse effect on either the reproductive capabilities or the course of pregnancy in rabbits and rats. Embryotoxic effects on the fetuses were not shown.

The daily administration of 4 mg/kg to 20 mg/kg pentazocine subcutaneously to female rats during a 14 day pre-mating period and until the 13th day of pregnancy did not have any adverse effects on the fertility rate.

There is no evidence in long-term animal studies to demonstrate that pentazocine is carcinogenic.

Pregnancy Category C

Animal reproduction studies have not been conducted with TALACEN. It is also not known whether TALACEN can cause fetal harm when administered to pregnant women or can affect reproduction capacity. TALACEN should be given to pregnant women only if clearly needed. However, animal reproduction studies with pentazocine have not demonstrated teratogenic or embryotoxic effects.

Nonteratogenic Effects

There has been no experience in this regard with the combination pentazocine and acetaminophen. However, there have been rare reports of possible abstinence syndromes in newborns after prolonged use of pentazocine during pregnancy.

Labor and Delivery

Patients receiving pentazocine during labor have experienced no adverse effects other than those that occur with commonly used analgesics. TALACEN should be used with caution in women delivering premature infants. The effect of TALACEN 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 TALACEN, on the later growth, development, and functional maturation of the child are unknown at the present time.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TALACEN is administered to a nursing woman.

Pediatric Use

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

Geriatric Use

Clinical studies of TALACEN 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 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: 9/19/2008

Manifestations

Clinical experience with TALACEN has been insufficient to define the signs of overdosage with this product. It may be assumed that signs and symptoms of TALACEN overdose would be a combination of those observed with pentazocine overdose and acetaminophen overdose.

For pentazocine alone in single doses above 60 mg there have been reports of the occurrence of nalorphine-like psychotomimetic effects such as anxiety, nightmares, strange thoughts, and hallucinations. Marked respiratory depression associated with increased blood pressure and tachycardia have also resulted from excessive doses as have dizziness, nausea, vomiting, lethargy, and paresthesias. The respiratory depression is antagonized by naloxone (see Treatment).

In acute acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may also occur.

In adults, a single dose of 10 g to 15 g (200 mg/kg to 250 mg/kg) of acetaminophen may cause hepatotoxicity. A dose of 25 g or more is potentially fatal. The potential seriousness of the intoxication may not be evident during the first two days of acute acetaminophen poisoning. During the first 24 hours, nausea, vomiting, anorexia, and abdominal pain occur. These may persist for a week or more. Liver injury may become evident the second day, initial signs being elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration, and prolongation of prothrombin time. Serum albumin concentration and alkaline phosphatase activity may remain normal. The hepatotoxicity may lead to encephalopathy, coma, and death. Transient azotemia is evident in a majority of patients and acute renal failure occurs in some.

There have been reports of glycosuria and impaired glucose tolerance, but hypoglycemia may also occur. Metabolic acidosis and metabolic alkalosis have been reported. Cerebral edema and non-specific myocardial depression have also been noted. Biopsy reveals centrolobular necrosis with sparing of the periportal area. The hepatic lesions are reversible over a period of weeks or months in nonfatal cases.

The severity of the liver injury can be determined by measurement of the plasma halftime of acetaminophen during the first day of acute poisoning. If the halftime exceeds 4 hours, hepatic necrosis is likely and if the halftime is greater than 12 hours, hepatic coma will probably occur. Only minimal liver damage has developed when the serum concentration was below 120 mcg/mL at 12 hours after ingestion of the drug. If serum bilirubin concentration is greater than 4 mg/100 mL during the first 5 days, encephalopathy may occur.

The seven day oral LD₅₀ value for TALACEN in mice is 3,570 mg/kg.

Treatment

Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered. For respiratory depression due to overdosage or unusual sensitivity to TALACEN, parenteral naloxone is a specific and effective antagonist.

The toxic effects of acetaminophen may be prevented or minimized by antidotal therapy with N-acetylcysteine. In order to obtain the best possible results, N-acetylcysteine should be administered within approximately 16 hours of ingestion of the overdose.

For complete prescribing information for the approved use of acetylcysteine in the treatment of acetaminophen overdose, see package insert for MUCOMYST® (acetylcysteine) Bristol-Myers Squibb.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication. Induction of vomiting or gastric lavage, followed by oral administration of activated charcoal should be done in all cases.

If hemodialysis can be initiated within the first 12 hours, it is advocated for patients with a plasma acetaminophen concentration exceeding 120 mcg/mL at 4 hours after ingestion of the drug.

TALACEN should not be administered to patients who are hypersensitive to either pentazocine or acetaminophen.

Last updated on RxList: 9/19/2008

TALACEN is an analgesic possessing antipyretic actions.

Pentazocine is an analgesic with agonist/antagonist action which when administered orally is approximately equivalent on a mg for mg basis in analgesic effect to codeine.

Acetaminophen is an analgesic and antipyretic.

Onset of significant analgesia with pentazocine 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, meperidine, and phenazocine; 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. Plasma levels closely correspond to the onset, duration, and intensity of analgesia. The time to mean peak concentration in 24 normal volunteers was 1.7 hours (range 0.5 to 4 hours) after oral administration and the mean plasma elimination half-life was 3.6 hours (range 1.5 to 10 hours).

The action of pentazocine is terminated for the most part by biotransformation in the liver with some free pentazocine excreted in the urine. The products of the oxidation of the terminal methyl groups and glucuronide conjugates are excreted by the kidney. Elimination of approximately 60% of the total dose occurs within 24 hours. Pentazocine passes the placental barrier.

Onset of significant analgesic and antipyretic activity of acetaminophen when administered orally occurs within 30 minutes and is maximal at approximately 2 1/2 hours. The pharmacological mode of action of acetaminophen is unknown at this time.

Acetaminophen is rapidly and almost completely absorbed from the gastrointestinal tract. In 24 normal volunteers the time to mean peak plasma concentration was 1 hour (range 0.25 to 3 hours) after oral administration and the mean plasma elimination half-life was 2.8 hours (range 2 to 4 hours).

The effect of pentazocine on acetaminophen plasma protein binding or vice versa has not been established. For acetaminophen there is little or no plasma protein binding at normal therapeutic doses. When toxic doses of acetaminophen are ingested and drug plasma levels exceed 90 mcg/mL, plasma binding may vary from 8% to 43%.

Acetaminophen is conjugated in the liver with glucuronic acid and to a lesser extent with sulfuric acid. Approximately 80% of acetaminophen is excreted in the urine after conjugation and about 3% is excreted unchanged. The drug is also conjugated to a lesser extent with cysteine and additionally metabolized by hydroxylation.

If TALACEN is taken every 4 hours over an extended period of time, accumulation of pentazocine and to a lesser extent, acetaminophen, may occur.

Last updated on RxList: 9/19/2008

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: 9/19/2008

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/ACETAMINOPHEN - ORAL

(pen-TAZZ-oh-seen/uh-seet-uh-MEE-no-fen)

COMMON BRAND NAME(S): Talacen

USES: This product is used to treat mild to moderate pain. It contains 2 medications, pentazocine and acetaminophen. Pentazocine is a narcotic pain reliever (opiate-type). It acts on certain centers in the brain to give you pain relief. Acetaminophen is a non-narcotic pain reliever.

HOW TO USE: Take this medication by mouth with or without food, usually every 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 increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed. Do not take more acetaminophen than recommended. (See also Side Effects and Precautions sections.)

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 any of these rare but very serious side effects occur: slow/shallow breathing, change in the amount of urine, signs of infection (such as fever, persistent sore throat), seizures, easy bruising/bleeding.

In adults who do not have liver problems, the maximum dose of acetaminophen is 4 grams a day (4000 milligrams). Taking more than the maximum daily amount may cause serious (possibly fatal) liver disease. Seek immediate medical attention if you have any of the following symptoms of liver damage: persistent nausea/vomiting, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, extreme tiredness.

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 acetaminophen; or to sulfites; 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.

This product contains acetaminophen, which may cause liver damage. Daily use of alcohol may increase your risk for liver damage, especially when combined with acetaminophen. Ask your doctor or pharmacist for more information.

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 product 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 product 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 pentazocine passes into breast milk. Acetaminophen 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/acetaminophen.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (such as warfarin), fluoxetine, isoniazid, MAO inhibitors (such as furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), phenothiazines (such as chlorpromazine, prochlorperazine, promethazine).

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 acetaminophen or ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Consult your pharmacist if you are uncertain whether your other prescription or nonprescription products contain acetaminophen. (See also maximum daily dose information in Side Effects section.)

This medication may interfere with certain medical/laboratory tests (including urine 5-HIAA), 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. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, severe drowsiness, severe dizziness, pinpoint pupils, severe nausea/vomiting, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, extreme tiredness.

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 medication 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 September 2008 Copyright(c) 2008 First DataBank, Inc.