TYLENOL®

McNeil Consumer ProductsAcetaminophenAnalgesic - Antipyretic

Indications And Clinical Uses: As a nonsalicylate analgesic-antipyretic for the relief of pain in a wide variety of conditions involving musculo/skeletal pain, as well as in other painful disorders such as headache, dysmenorrhea, myalgias, neuralgias. Also indicated for the symptomatic reduction of fever due to the common cold, flu and other viral or bacterial infections.

Contra-Indications: Hypersensitivity to acetaminophen.

Adverse Reactions: When used as directed, acetaminophen is virtually free of severe toxicity or side effects. In contrast to salicylates, gastrointestinal irritation rarely occurs with acetaminophen. If a rare hypersensitivity reaction occurs, discontinue the drug. Hypersensitivity is usually manifested by a rash or urticaria.

Regular use of acetaminophen has been shown to produce a slight increase in prothrombin time in patients receiving oral anticoagulants but the clinical significance of this effect is not clear.

Symptoms And Treatment Of Overdose: Acetaminophen poisoning can result in severe hepatic damage. The minimal dose of acetaminophen that may cause hepatotoxicity in adults is generally considered to be 10 g and a dose of 15 g is potentially lethal. However, there have been rare instances of hepatotoxicity and death reported from lower doses and survival after much larger doses (up to 31 g) is not uncommon.

Phenobarbital increases the activity of microsomal enzymes which produce the toxic metabolite and therefore acetaminophen's hepatotoxicity may be enhanced. Thus, concomitant ingestion of phenobarbital may increase the likelihood of liver necrosis in acetaminophen overdose. The chronic ingestion of alcohol may also increase the potential for hepatic toxicity in acetaminophen overdose.Symptoms: Early symptoms (nausea, vomiting, weakness, diaphoresis) usually occur after ingestion of an acetaminophen overdose large enough to cause hepatic toxicity. However, since some patients may exhibit few or none of these early signs, in cases of suspected acetaminophen overdose, antidotal therapy should begin as soon as possible. A latent period of 24 to 36 hours exists between ingestion and the onset of symptoms of hepatic injury. Laboratory evidence usually appears within 24 to 48 hours if severe hepatotoxicity is to occur. In mild cases, clinical evidence of hepatotoxicity may be delayed for as long as 5 days. Consequently, overdose patients should be monitored by liver function tests for several days following the overdose. Following the latent period, vomiting, pain in the right hypochondrium and manifestations of hepatic failure including the onset of coma may ensue. Maximum hepatic necrosis appears 2 to 5 days following overdose. The predominant changes in serum chemistries are a gross elevation of hepatic enzymes (ALT, AST), an elevation of serum bilirubin, a prolongation of prothrombin time and possible hypoglycemia.

In addition to hepatic damage, clotting defects, and myocardial damage with ST segment abnormalities, T wave flattening and pericarditis have been reported.

Treatment: When the possibility of overdose exists, treatment should be immediate and should include appropriate decontamination of the gastrointestinal tract, proper supportive care, timely administration of n-acetylcysteine which is an effective drug in preventing acetaminophen induced hepatotoxicity and appropriate follow-up. Properly timed plasma acetaminophen levels are key prognosticators in determining a patient's risk for hepatotoxicity post overdose. These measurements may be of prognostic value if they are carried out no sooner than 4 hours after the overdose. An assay of a specimen collected in less than 4 hours after the overdose may be misleading since peak plasma (serum) concentrations in overdose patients may occur as late as 4 hours or more after ingestion. Plot the results of the appropriately timed plasma acetaminophen tests on the Matthew-Rumack Nomogram to estimate the patient's risk status. However, if massive acetaminophen ingestion is known or suspected, the antidote should not be withheld until these determinations have been made.

Avoid the following in treating patients with acetaminophen overdose: drugs having a potential for hepatotoxicity; antihistamines; CNS depressants, including barbiturates; diuretics (especially ethacrynic acid and furosemide); forced diuresis, hemoperfusion or hemodialysis have no proven benefit on management of uncomplicated acetaminophen overdose.

Appropriate decontamination of the gastrointestinal tract should be commenced as soon as possible. Activated charcoal may impair the absorption of orally administered n-acetylcysteine; however, the clinical significance of this interference is unclear. When charcoal has been administered, it may be preferable to use the i.v. formulation of n-acetylcysteine. The role of cathartics is controversial. The routine use of cimetidine in acetaminophen poisoning remains unproven.

Institute supportive treatment. Maintain fluid and electrolyte balance. Treat as necessary for hypoglycemia. Administer vitamin K1 if the prothrombin time ratio exceeds 1.5. Add fresh frozen plasma or clotting factor concentrate if the ratio exceeds 3.0.

During follow-up, if hepatic or renal impairment develops, monitor until the laboratory parameters return to normal. Acute renal failure may develop in the presence of severe liver damage or rarely, even in the absence of liver failure. Use serum creatinine to monitor renal function.

Clinical studies indicate that prompt antidotal therapy with acetylcysteine decreases the risk of acetaminophen induced hepatic injury. Acetylcysteine is available in Canada as an antidote in oral and i.v. dosage forms. Call the nearest Poison Control Centre or consult approved acetylcysteine monographs for specific treatment regimens using these products.

Dosage And Administration: Adults: 650 to 1 000 mg every 4 to 6 hours, not to exceed 4 000 mg acetaminophen/24 hours. May be administered with or without food.

Children: 10 to 15 mg/kg every 4 to 6 hours, not to exceed 65 mg/kg/24 hours; or the following (see Table I), 4 to 5 times daily, with or without food i.e. milk, formula, juices, etc.

Availability And Storage: Caplets: 325 mg: Each elongated, capsule-shaped white tablet, engraved “TYLENOL” one side and “325” on the other, contains: acetaminophen 325 mg. Nonmedicinal ingredients: cellulose, cornstarch, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol and sodium starch glycolate. Energy: 0.7 kJ (0.2 kcal). Sodium: <1 mmol (0.3 mg). Gluten-, lactose- and tartrazine-free. Plastic bottles of 24†, 50†, 100† and 200.

500 mg: Each elongated, capsule-shaped white tablet, engraved “TYLENOL” one side and “500” on the other, contains: acetaminophen 500 mg. Nonmedicinal ingredients: cellulose, cornstarch, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol and sodium starch glycolate. Energy: 0.8 kJ (0.2 kcal). Sodium: <1 mmol (0.4 mg). Gluten-, lactose- and tartrazine-free. Plastic bottles of 24†, 50†, 100† and 150.

Chewable Tablets: Fruit: 80 mg: Each round, pink tablet, engraved “TYLENOL” one side and “80” with a partial score the other side, contains: acetaminophen 80 mg. Nonmedicinal ingredients: cellulose, citric acid, compressible sugar, D&C Red No. 7, ethylcellulose, flavoring, magnesium stearate, mannitol and sodium cyclamate. Energy: 5 kJ (1.2 kcal). Sodium: <1 mmol (0.6 mg). Gluten-, lactose- and tartrazine-free. Plastic bottles of 24†.

Chewable Tablets: Sucrose-Free Bubble Gum: 80 mg: Each round, rose tablet engraved “TYLENOL” one side and “80” with a partial score the other side contains: acetaminophen 80 mg. Nonmedicinal ingredients: aspartame, cellulose, D&C Red No. 7, flavoring, magnesium stearate and mannitol. Phenylketonurics: contains phenylalanine (aspartame). Energy: 4.2 kJ (1 kcal). Gluten-, lactose-, sodium-, sugar- (as sucrose) and tartrazine-free. Plastic bottles of 24†.

Chewable Tablets: Sucrose-Free Grape: 80 mg: Each round, purple tablet, engraved “TYLENOL” one side and “80” with a partial score the other side, contains: acetaminophen 80 mg. Nonmedicinal ingredients: aspartame, cellulose, citric acid, D&C Red No. 7, ethylcellulose, FD&C Blue No. 1, flavoring, magnesium stearate and mannitol. Phenylketonurics: contains phenylalanine (aspartame). Energy: 4.2 kJ (1 kcal). Gluten-, lactose-, sodium-, sugar- (as sucrose) and tartrazine-free. Plastic bottles of 24†.

Children's Elixir: Each 5 mL contains: acetaminophen 160 mg in a cherry-flavored red vehicle. Nonmedicinal ingredients: benzoic acid, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol and sucrose. Energy: 36.7 kJ (8.8 kcal). Sodium: <1 mmol (1.2 mg). Alcohol-, gluten-, lactose- and tartrazine-free. Plastic bottles of 100 mL† and amber glass bottles of 500 mL.

Children's Suspension Liquid: Bubble Gum Flavor: Each 5 mL contains: acetaminophen 160 mg in a dark pink liquid vehicle with a bubble gum-flavored taste. Nonmedicinal ingredients: butylparaben, cellulose, citric acid, corn syrup, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol and xanthan gum. Energy: 51 kJ (12 kcal). Sodium: <1 mmol. Alcohol-, gluten-, lactose- and tartrazine-free. Plastic botles of 100 mL†.

Children's Suspension Liquid: Grape Flavor: Each 5 mL contains: acetaminophen 160 mg in a purple liquid vehicle with a grape-flavored taste. Nonmedicinal ingredients: butylparaben, cellulose, citric acid, corn syrup, D&C Red No. 33, FD&C Blue No. 1, flavoring, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol and xanthan gum. Energy: 46 kJ (11 kcal). Sodium: <1 mmol (1.6 mg). Alcohol-, gluten-, lactose- and tartrazine-free. Plastic bottles of 100 mL†.

Gelcaps: 500 mg: Each solid capsule-shaped tablet, coated with red gelatin on one end and yellow on the other, printed “TYLENOL/500” on each gelatin-coated end, contains: acetaminophen 500 mg. Nonmedicinal ingredients: benzyl alcohol, butylparaben, castor oil, cornstarch, cellulose, edetate calcium disodium, gelatin, hydroxypropyl methycellulose, magnesium stearate, methylparaben, propylparaben, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide, FD&C Blue No. 1 and No. 2, FD&C Red No. 40, D&C Yellow No. 10. Energy: 1 kJ (0.2 kcal). Sodium: <1 mmol (0.42 mg). Gluten-, lactose- and tartrazine-free. Plastic bottles of 24† and 50.

Infants' Drops: Each mL contains: acetaminophen 80 mg in an orange liquid vehicle with a fruit-flavored taste. Nonmedicinal ingredients: citric acid, FD&C Yellow No. 6, flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium cyclamate and sorbitol. Energy: 4.1 kJ (0.98 kcal). Sodium: <1 mmol (1.4 mg). Tartrazine-, gluten-, alcohol- and lactose-free. Plastic bottles of 15 mL† and 24 mL† with a calibrated dropper. Concentrated for dropper dosage only.

Infants' Suspension Drops: Each mL contains: acetaminophen 80 mg in a purple liquid vehicle with a grape-flavored taste. Nonmedicinal ingredients: butylparaben, cellulose, citric acid, corn syrup, D&C Red No. 33, FD&C Blue No. 1, flavoring, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol and xanthan gum. Energy: 8.8 kj (2.1 kcal). Sodium: <1 mmol (0.3 mg). Alcohol-, gluten-, lactose- and tartrazine-free. Plastic bottles of 15 mL†, 24 mL† with a calibrated dropper. Concentrated for dropper dosage only.

Junior Strength Chewable Tablets: Sucrose-Free Grape: 160 mg: Each round, purple tablet, scored on one side and engraved “TYLENOL 160” the other side, contains: acetaminophen 160 mg. Nonmedicinal ingredients: aspartame, cellulose, citric acid, D&C Red No. 7, ethylcellulose, FD&C Blue No. 1, flavoring, magnesium stearate and mannitol. Phenylketonurics: contains phenylalanine (aspartame). Energy: 8 kJ (2.0 kcal). Gluten-, lactose-, sodium-, sugar- (as sucrose) and tartrazine-free. Blister packs of 20.†

Junior Strength Caplets: 160 mg: Each elongated, capsule-shaped, white tablet, scored on one side and engraved “TYLENOL 160” the other side, contains: acetaminophen 160 mg. Nonmedicinal ingredients: cellulose, cornstarch hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol and sodium starch glycolate. Energy: 0.3 kJ (0.1 kcal). Sodium: <1 mmol (0.1 mg). Gluten-, lactose- and tartrazine-free. Blister packs of 20†.

Junior Strength Chewable Tablets: Fruit: 160 mg: Each round, pink tablet, scored on one side and engraved “TYLENOL 160” the other side, contains: acetaminophen 160 mg. Nonmedicinal ingredients: cellulose, citric acid, compressible sugar, D&C Red No. 7, ethylcellulose, flavoring, magnesium stearate, mannitol and sodium cyclamate. Energy: 10 kJ (2.5 kcal). Sodium: <1 mmol (1.1 mg). Gluten-, lactose- and tartrazine-free. Blister packs of 20†.

Tablets: 325 mg: Each round, white tablet, engraved “TYLENOL” one side and “325” the other side, contains: acetaminophen 325 mg. Nonmedicinal ingredients: cellulose, cornstarch, magnesium stearate and sodium starch glycolate. Energy: 0.8 kJ (0.2 kcal). Sodium: <1 mmol (0.1 mg). Gluten-, lactose- and tartrazine-free. Plastic bottles of 24†, 50†, 100 and 500.

500 mg: Each round, white tablet, engraved “TYLENOL” one side and “500” other side, contains: acetaminophen 500 mg. Nonmedicinal ingredients: cellulose, cornstarch, magnesium stearate and sodium starch glycolate. Energy: 1.3 kJ (0.3 kcal). Sodium: <1 mmol (0.1 mg). Gluten-, lactose- and tartrazine-free. Plastic bottles of 30†, 50 and 100†.

†Container provided with a child-resistant closure.

All packages are safety sealed.

Reviewed Reviewed 1996