(WARNING: May be habit forming)

Aspirin (acetylsalicylic acid) occurs as white crystals, commonly tabular or needle-like, or white, crystalline powder. It is odorless or has a faint odor. Its chemical name is: 2-(acetyloxy)benzoic acid. Its molecular formula is:

C₉H₈O₄ with a molecular weight of 180.16

Codeine is an alkaloid, obtained from opium or prepared from morphine by methylation. Codeine phosphate occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is odorless and is affected by light. Its chemical name is: 7,8-didehydro-4,5oe epoxy-3-methoxy-17~ methylmorphinan~6oe-ol phosphate (1 :1) (salt) hemihydrate. Its molecular formula is:

C₁₈H₂₁NO₃†H₃PO₄†1/2 H₂O with a molecular weight of 406.37

Aspirin and codeine phosphate tablets for oral administration combine the following inactive ingredients: colloidal silicon dioxide, corn starch, microcrystalline cellulose, povidone, and stearic acid.

Last updated on RxList: 12/8/2004

Aspirin and codeine phosphate tablets are indicated for the relief of mild, moderate, and moderate to severe pain.

Dosage is adjusted according to the severity of pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below when pain is severe or the patient has become tolerant to the analgesic effect of codeine. Aspirin and codeine phosphate tablets are given orally. The usual adult dose for Aspirin and Codeine 30 mg is one or two tablets every four hours as required. The usual adult dose for Aspirin and Codeine 60 mg is one tablet every four hours as required.

Aspirin and codeine phosphate tablets should be taken with food or a full glass of milk or water to lessen gastric irritation.

Aspirin and codeine phosphate tablets are available as:

325 mg/30 mg...........white, round, unscored tablets, debossed "3984" on one side and "3" on the other packaged in bottles of 100 and 1000 tablets.

325 mg/60 mg.......... white, round, unscored tablets, debossed "3985" on one side and "4" on the other packaged in bottles of 100 and 500 taablets.

PHARMACIST: Dispense in a well-closed, light-resistant container as defined in the USP. Use child- resistant closure. Store at controlled room temperature 15°-30° C( 59°-86° F). PROTECT FROM MOISTURE.

CAUTION: Federal law prohibits dispensing without prescription.

Last updated on RxList: 12/8/2004

Codeine

The most frequently observed adverse reactions to codeine include light-headedness, dizziness, drowsiness, nausea, vomiting, constipation and depression of respiration. Less common reactions to codeine include euphoria, dysphoria, pruritus and skin rashes.

Aspirin

Mild aspirin intoxication (salicylism) can occur in response to chronic use of large doses. Manifestations include nausea, vomiting, hearing impairment, tinnitus, diminished vision, headache, dizziness, drowsiness, mental confusion, hyperpnea, hyperventilation, tachycardia, sweating and thirst.

Therapeutic doses of aspirin can induce mild or severe allergic reactions manifested by skin rashes, urticaria, angioedema, rhinorrhea, asthma, abdominal pain, nausea, vomiting, or anaphylactic shock. A history of allergy is often lacking, and allergic reactions may occur even in patients who have previously taken aspirin without any ill effects. Allergic reactions to aspirin are most likely to occur in patients with a history of allergic disease, especially in patients with nasal polyps or asthma.

Some patients are unable to take aspirin or other salicylates without developing nausea or vomiting. Occasional patients respond to aspirin (usually in large doses) with dyspepsia or heartburn, which may be accompanied by occult bleeding. Excessive bruising or bleeding is sometimes seen in patients with mild disorders of primary hemostasis who regularly use low doses of aspirin.

Prolonged use of aspirin can cause painless erosion of gastric mucosa, occult bleeding and infrequently, iron-deficiency anemia. High doses of aspirin can exacerbate symptoms of peptic ulcer and occasionally, cause extensive bleeding.

Excessive bleeding can follow injury or surgery in patients with or without known bleeding disorders who have taken therapeutic doses of aspirin within the preceding 10 days. Hepatotoxicity has been reported in association with prolonged use of large doses of aspirin in patients with lupus erythematosus, rheumatoid arthritis and rheumatic disease. Bone marrow depression, manifested by weakness, fatigue, or abnormal bruising or bleeding, has occasionally been reported. In patients with glucose-6-phosphate dehydrogenase deficiency, aspirin can cause a mild degree of hemolytic anemia. In hyperuricemic persons, low doses of aspirin may reduce the effectiveness of uricosuric therapy or precipitate an attack of gout.

DRUG ABUSE AND DEPENDENCE

Like other medications containing a narcotic analgesic, aspirin and codeine phosphate tablets are controlled by the Drug Enforcement Administration and is classified under Schedule III.

Aspirin and codeine can produce drug dependence of the morphine type; therefore, it has a potential for being abused. Psychic dependence, physical dependence and tolerance may develop on repeated administration.

The dependence liability of codeine has been found to be too small to permit a full definition of its characteristics. Studies indicate that addiction to codeine is extremely uncommon and requires very high parenteral doses.

When dependence on codeine occurs at therapeutic doses, it appears to require from one to two months to develop, and withdrawal symptoms are mild. Most patients on long-term oral codeine therapy show no signs of physical dependence upon abrupt withdrawal.

Aspirin and codeine phosphate tablets may enhance the effects of:

(1) monoamine oxidase (MAO) inhibitors,

(2) oral anticoagulants, causing bleeding by inhibiting prothrombin formation in the liver and displacing anticoagulants from plasma protein binding sites,

(3) oral antidiabetic agents and insulin, causing hypoglycemia by contributing an additive effect, and by displacing the oral antidiabetic agents from secondary binding sites,

(4) 6-mercaptopurine and methotrexate, causing bone marrow toxicity and blood dyscrasias by displacing these drugs from secondary binding sites,

(5) penicillins and sulfonamides, increasing their blood levels by displacing these drugs from protein binding sites,

(6) non-steroidal anti-inflammatory agents, increasing the risk of peptic ulceration and bleeding by contributing additive effects,

(7) other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression,

(8) corticosteroids, potentiating steroid anti-inflammatory effects by displacing steroids from protein binding sites. Aspirin intoxication may occur with corticosteroid withdrawal because steroids promote renal clearance of salicylates.

Aspirin and codeine phosphate tablets may diminish the effects of: uricosuric agents such as probenecid and sulfinpyrazone, reducing their effectiveness in the treatment of gout. Aspirin competes with these agents for protein binding sites. Aspirin and its metabolites may be caused to accumulate in the body, perhaps to toxic levels, by para-aminosalicylic acid, furosemide, and vitamin C.

Drug/Laboratory Test Interactions

Aspirin: Aspirin may interfere with the following laboratory determinations in blood: serum amylase, fasting blood glucose, carbon dioxide, cholesterol, protein, protein bound iodine, uric acid, prothrombin time, bleeding time, and spectrophotometric detection of barbiturates.

Aspirin may interfere with the following laboratory determinations in urine: glucose, 5-hydroxyindoleacetic acid, Gerhardt ketone, vanillylmandelic acid (VMA), protein, uric acid, and diacetic acid.

Codeine: Codeine may increase serum amylase levels.

Last updated on RxList: 12/8/2004

Therapeutic doses of aspirin can cause anaphylactic shock and other severe allergic reactions. A history of allergy is often lacking.

Significant bleeding can result from aspirin therapy in patients with peptic ulcer or other gastrointestinal lesions, and in patients with bleeding disorders. Aspirin administered preoperatively may prolong the bleeding time.

In the presence of head injury or other intracranial lesions, the respiratory depressant effects of codeine and other narcotics may be markedly enhanced, as well as their capacity for elevating cerebrospinal fluid pressure. Narcotics also produce other CNS depressant effects, such as drowsiness, that may further obscure the clinical course of patients with head injuries.

Codeine or other narcotics may obscure signs on which to judge the diagnosis or clinical course of patients with acute abdominal conditions. Results from pilot epidemiologic studies suggest an association between aspirin and Reye-Syndrome. Caution should be used in administering this product to children, including teenagers, with chicken pox or flu.

General

Aspirin and codeine phosphate tablets should be prescribed with caution for certain special-risk patients such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, gallbladder disease or gallstones, respiratory impairment, cardiac arrhythmias, inflammatory disorders of the gastrointestinal tract, hypothyroidism, Addison†s disease, prostatic hypertrophy or urethral stricture, coagulation disorders, head injuries, or acute abdominal conditions. Aspirin and codeine phosphate tablets should not be prescribed for long-term therapy unless specifically indicated.

Precautions should be taken when administering salicylates to persons with known allergies. Hypersensitivity to aspirin is particularly likely in patients with nasal polyps, and relatively common in those with asthma.

Laboratory Tests

Hypersensitivity to aspirin cannot be detected by skin testing or radioimmunoassay procedures. The primary screening tests for detecting a bleeding tendency are platelet count, bleeding time, activated partial thromboplastin time and prothrombin time. In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate long-term studies have been conducted in animals to determine whether codeine has a potential for carcinogenesis, mutagenesis, or impairment of fertility. Adequate long-term studies have been conducted in mice and rats with aspirin, alone or in combination with other drugs, in which no evidence of carcinogenesis was seen. No adequate studies have been conducted in animals to determine whether aspirin has a potential for mutagenesis or impairment of fertility.

Pregnancy

Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with aspirin and codeine. It is also not known whether aspirin and codeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aspirin and codeine should be given to a pregnant woman only if clearly needed.

Reproductive studies in rats and mice have shown aspirin to be teratogenic and embryocidal at four to six times the human therapeutic dose. Studies in pregnant women, however, have not shown that aspirin increases the risk of abnormalities when administered during the fist trimester of pregnancy. In controlled studies involving 41,337 pregnant women and their offspring, there was no evidence that aspirin taken during pregnancy caused stillbirth, neonatal death or reduced birth weight. In controlled studies of 50,282 pregnant women and their offspring, aspirin administration in moderate and heavy doses during the first four lunar months of pregnancy showed no teratogenic effect.

Reproduction studies have been performed in rabbits and rats at doses at up to 150 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to codeine.

Nonteratogenic Effects: Therapeutic doses of aspirin in pregnant women close to term may cause bleeding in mother, fetus, or neonate. During the last six months of pregnancy, regular use of aspirin in high doses may prolong pregnancy and delivery.

Labor and Delivery

Ingestion of aspirin prior to delivery may prolong delivery or lead to bleeding in the mother or neonate. Use of codeine during labor may lead to respiratory depression in the neonate.

Nursing Mothers

Aspirin and codeine are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of the potential for serious adverse reactions in nursing infants from aspirin and codeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Last updated on RxList: 12/8/2004

Severe intoxication, caused by overdose of aspirin and codeine, may produce: skin eruptions, dyspnea, vertigo, double vision, delusions, hallucinations, garbled speech, excitability, restlessness, delirium, constricted pupils, a positive Babinski sign, respiratory depression (slow and shallow breathing; Cheyne-Stokes respiration), cyanosis, clammy skin, muscle flaccidity, circulatory collapse, stupor and coma. In children, difficulty in hearing, tinnitus, dim vision, headache, dizziness, drowsiness, confusion, rapid breathing, sweating, thirst, nausea, vomiting, hyperpyrexia, dehydration and convulsions are prominent signs. The most severe manifestations from aspirin result from cardiovascular and respiratory insufficiency secondary to acid-base and electrolyte disturbances, complicated by hyperthermia and dehydration. The most severe manifestations from codeine are associated with respiratory depression.

Respiratory alkalosis is characteristic of the early phase of intoxication with aspirin while hyperventilation is occurring, but is quickly followed by metabolic acidosis in most people with severe intoxication. This occurs more readily in children. Hypoglycemia may occur in children who have taken large overdoses. Other laboratory findings associated with aspirin intoxication include ketonuria, hyponatremia, hypokalemia, and occasionally, proteinuria. A slight rise in lactic dehydrogenase and hydroxybutyric dehydrogenase may occur.

Concentrations of aspirin in plasma above 30 mg/100 mL are associated with toxicity. (See CLINICAL PHARMACOLOGY section for information on factors influencing aspirin blood levels.) The single lethal dose of aspirin in adults is probably about 25-30 g, but is not known with certainty.

The toxic plasma concentration of codeine is not known with certainty. Experimental production of mild to moderate CNS depression in healthy, nontolerant subjects occurred at plasma concentrations of 0.05-0.19 mg/100 mL when codeine was given by intravenous infusion. The single lethal dose of codeine in adults is estimated to be from 0.5-1.0 g. It is also estimated that 5 mg/kg could be fatal in children. Hemodialysis and peritoneal dialysis can be performed to reduce the body aspirin content. Codeine is theoretically dialyzable but the procedure has not been clinically established.

Treatment of overdosage consists primarily of support of vital functions, management of codeine-induced respiratory depression, increasing salicylate elimination, and correcting the acid-base imbalance due primarily to salicylism.

In a comatose patient, primary attention should be given to establishment of adequate respiratory exchange through provisions of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone is a specific antidote for respiratory depression which may result from Overdose or unusual sensitivity to narcotics. Therefore, an appropriate dose of an antagonist should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of aspirin and 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. A narcotic antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.

Gastric emptying (Syrup of Ipecac) and/or lavage is recommended as soon as possible after ingestion, even if the patient has vomited spontaneously. (Apomorphine should not be used as an emetic for aspirin and codeine, since it may potentiate hypotension and respiratory depression.) Administration of activated charcoal as a slurry is beneficial after lavage and or emesis, if less than three hours have passed since ingestion. Charcoal adsorption should not be employed prior to emesis or lavage.

Severity of aspirin intoxication is determined by measuring the blood salicylate level. Acid-base status should be closely followed with serial blood gas and serum pH measurements. Fluid and electrolyte balance should also be regularly monitored.

A serum salicylate level of 30 mg/100 mL or higher indicates a need for enhanced salicylate excretion that can be achieved through body-fluid supplementation and urine alkalinization if renal function is normal. In mild intoxication, urine flow can be increased by forcing oral fluids and giving potassium citrate capsules. (DO NOT GIVE BICARBONATE BY MOUTH SINCE IT INCREASES THE R.T. OF SALICYLATE ABSORPTION.)

In severe cases, hyperthermia and hypovolemia, as well as respiratory depression are the major immediate threats to life. Children should be sponged with tepid water. Replacement fluid should be administered intravenously and augmented with sufficient bicarbonate to correct acidosis, with monitoring of plasma electrolytes and pH, to promote alkaline diuresis of salicylate if renal function is normal. Complete control may also require infusion of glucose to control hypoglycemia. Potassium deficiency may also be corrected through the infusion, once adequate urinary output is assured. Plasma or plasma expanders may be needed if fluid replacement is insufficient to maintain normal blood pressure or adequate urinary output.

In patients with renal insufficiency or in cases of life-threatening intoxication, dialysis is usually required. Peritoneal dialysis or exchange-transfusion is indicated in infants and young children, and hemodialysis in older patients. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as needed.

Aspirin and codeine phosphate is contraindicated under the following conditions:

(1) hypersensitivity or intolerance to aspirin or codeine,

(2) severe bleeding, disorders of coagulation or primary hemostasis, including hemophilia, hypoprothrombinemia, von Willebrand†s disease, the thrombocytopenias, thrombasthenia and other ill-defined hereditary platelet dysfunctions, as well as such associated conditions as severe vitamin K deficiency and severe liver damage,

(3) anticoagulant therapy, and

(4) peptic ulcer, or other serious gastrointestinal lesions.

Last updated on RxList: 12/8/2004

Aspirin

The analgesic, anti-inflammatory and antipyretic effects of aspirin are believed to result from inhibition of the synthesis of certain prostaglandins. Aspirin interferes with clotting mechanisms primarily by diminishing platelet aggregation; at high doses prothrombin synthesis can be inhibited.

Aspirin in solution is rapidly absorbed from the stomach and from the upper small intestine. About 50 percent of an oral dose is absorbed in 30 minutes and peak plasma concentrations are reached in about 40 minutes. Higher than normal stomach pH or the presence of food slightly delays absorption.

Once absorbed, aspirin is mainly hydrolyzed to salicylic acid and distributed to all body tissues and fluids, including fetal tissue, breast milk and the central nervous system (CNS). Highest concentrations are found in plasma, liver, renal cortex, heart and lung. From 50 to 80 percent of the salicylic acid and its metabolites in plasma are loosely bound to proteins. The plasma half- life of total salicylate is about 3.0 hours, with a 650 mg dose. Higher doses of aspirin cause increases in plasma salicylate half- life. Metabolism occurs primarily in the hepatocytes. The major metabolites are salicyluric acid (75%), the phenolic and acyl glucuronides of salicylate (15%), and gentisic and gentisuric acid (< 1%).

Almost all of a therapeutic dose of aspirin is excreted through the kidneys, either as sailcylic acid or the above mentioned metabolic products. Renal clearance of salicylates is greatly augmented by an alkaline urine, as is produced by concurrent administration of sodium bicarbonate or potassium citrate.

Toxic salicylate blood levels are usually above 30 mg/ 100 mL. The single lethal dose of aspirin in normal adults is approximately 25- 30 g, but patients have recovered from much larger doses with appropriate treatment.

Codeine

Codeine probably exerts its analgesic effect through actions on opiate receptors in the CNS. Codeine is readily absorbed from the gastrointestinal tract, and a therapeutic dose reaches peak analgesic effectiveness in about 2 hours and persists for 4 to 6 hours. Oral codeine (60 mg) given to healthy males has been shown to achieve peak blood levels of 0.016 mg/100 mL at approximately one hour post-dose. The codeine plasma half-life for a 60 mg oral dose is about 2.9 hours. Blood levels causing CNS depression begin at 0.05-0.19 mg/100 mL. The single lethal dose of codeine in adults is estimated to be approximately 0.5-1.0 g. Codeine is rapidly distributed from blood to body tissues and taken up preferentially by parenchymatous organs such as liver, spleen and kidney. It passes the blood-brain barrier and is found in fetal tissue and breast milk.

The drug is not bound by plasma proteins nor is it accumulated in body tissues. Codeine is metabolized in liver to morphine and norcodeine, each representing about 10 percent of the administered dose of codeine. About 90 percent of the dose is excreted within 24 hours, primarily through the kidneys. Urinary excretion products are free and glucuronide-conjugated codeine (about 70%), free and conjugated norcodeine (about 10%), free and conjugated morphine (about 10%), normorphine (under 4%) and hydrocodone (<1%). The remainder of the dose appears in the feces.

Last updated on RxList: 12/8/2004

Aspirin and 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. Such tasks should be avoided while taking aspirin and codeine. Alcohol and other CNS depressants may produce an additive CNS depression when taken with aspirin and codeine, and should be avoided.

Codeine may be habit-forming when used over long periods or in high doses. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Last updated on RxList: 12/8/2004

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.

ASPIRIN/CODEINE - ORAL

(ASP-er-in/KO-deen)

USES: This product is used to treat mild to moderate pain. It contains 2 medications, aspirin and codeine. Aspirin helps to decrease pain and swelling. Codeine is a narcotic pain reliever (opiate-type) that acts on certain centers in the brain to give you pain relief.

HOW TO USE: Take this medication by mouth with or without food, usually every 4 hours as needed or as directed by your doctor. Take it with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 30 minutes after taking this product. To help prevent stomach upset or nausea, take it with food. Consult your doctor or pharmacist about other ways to decrease nausea (such as taking antihistamines).

The dosage is based on your medical condition and response to treatment. If you are extremely drowsy after using this medication, consult your doctor or pharmacist promptly. Your dosage may need to be lowered.

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

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, upset stomach, heartburn, 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: slow/shallow breathing, mental/mood changes (such as agitation, confusion, hallucinations), fainting, difficulty urinating, hearing changes (such as ringing in the ears, hearing loss), vision changes, fast/slow heartbeat, easy bruising/bleeding.

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, black/bloody stools, vomit that looks like coffee grounds, unusual tiredness, yellowing eyes/skin, dark urine, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 aspirin or codeine; or to salicylates (such as salsalate), nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen, naproxen, celecoxib), or to narcotic pain medications (such as morphine); 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: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), certain stomach/bowel diseases (paralytic ileus, infectious diarrhea), bleeding/blood clotting disorders (such as hemophilia, von Willebrand's disease, thrombocytopenia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung diseases (such as asthma, chronic obstructive pulmonary disease-COPD), breathing problems (such as slow/shallow breathing, sleep apnea), a certain spinal problem (kyphoscoliosis), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), personal or family history of regular use/abuse of drugs/alcohol, certain heart problems (irregular heartbeat, heart failure), brain disorders/injuries (such as seizures, head injury, tumor, increased intracranial pressure), underactive thyroid (hypothyroidism), gallbladder disease, disease of the pancreas (such as pancreatitis), adrenal gland problems (such as Addison's disease), mental/mood disorders (such as toxic psychosis), stomach/intestinal disorders (such as colitis, blockage, ulcer), heartburn, gout, growths in the nose (nasal polyps), certain enzyme deficiencies (pyruvate kinase deficiency, G6PD deficiency).

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Avoid alcoholic beverages because they may increase the risk of this drug's side effects.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Avoid alcohol and stop smoking. Consult your doctor or pharmacist for more information.

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

This drug contains aspirin. Children and teenagers should not take aspirin if they have chickenpox, flu, or any undiagnosed illness or if they have recently received a vaccine. In these cases, taking aspirin increases the risk of Reye's syndrome, a rare but serious illness.

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

During the first 6 months of pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. 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.

This product passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.

DRUG INTERACTIONS: 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: mifepristone, naltrexone, ketorolac.

If you are currently using any of these medications, tell your doctor or pharmacist before starting this product.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: ACE inhibitors (such as captopril, lisinopril), carbonic anhydrase inhibitors (such as acetazolamide), bisphosphonates taken by mouth (such as alendronate), "blood thinners" (such as warfarin, enoxaparin, clopidogrel), corticosteroids (such as prednisone, dexamethasone), certain antidepressants (SSRIs such as fluoxetine/sertraline, SNRIs such as duloxetine), certain drugs to treat diabetes (sulfonylureas such as glyburide/glipizide), certain medications for gout (probenecid, sulfinpyrazone), ginkgo biloba, mercaptopurine, methotrexate, certain medications for pain (opiate partial agonists such as butorphanol, nalbuphine, pentazocine), pemetrexed, quinidine, salicylates (such as salsalate), valproic acid.

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, other narcotic pain relievers (such as morphine), and psychiatric medicines (such as risperidone, amitriptyline, trazodone). Your medications or doses of your medications may need to be changed.

Check the labels on all your medicines (such as cough-and-cold products, pain relievers/fever reducers) because they may contain aspirin or aspirin-related drugs (NSAIDs such as ibuprofen or naproxen) or ingredients that may cause drowsiness. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This product may interfere with certain laboratory tests (including blood amylase levels, urine glucose levels, urine 5-HIAA levels, urine VMA levels), 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: severe drowsiness, slow/shallow breathing, pinpoint pupils, severe dizziness, ringing in the ears.

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: Not applicable.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. 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.