Tylenol

White film coated caplet debossed with "TYLENOL" over "ER" on one side.
Each tablet contains: Paracetamol, USP 650 mg.

Analgesic/antipyretic.

Temporary relief of mild to moderate aches and pains.
Fever reduction.

How much and how often should the patient use this medicine: Adults and children 12 years and over: For adults and children 12 years of age and older, take 2 tablets every 8 hours. Do not take more than 6 tablets in 24 hours.
Do not use more than 10 days unless directed by the doctor.
Not recommended for children under 12 years of age.
What should the patient do if they miss a dose: Continue medication based on dosage and/or consult the doctor.

Signs and Symptoms of Overdose: Hepatobiliary Disorders: If a paracetamol extended-release product is involved or if the exact formulation is not known, it is recommended to obtain an additional plasma paracetamol level 4 to 6 hours following the initial paracetamol level as these levels will continue to rise with the extended release products and may alter treatment decisions.
In adults and adolescents (2:12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 g over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdose may include: Anorexia, nausea, vomiting, diaphoresis, pallor and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Serious toxicity or fatalities have been extremely infrequent following an acute paracetamol overdose in young children, possibly because of differences in the way they metabolize paracetamol.
Table 1 shows the clinical events associated with paracetamol overdose that if seen with overdose are considered expected, including fatal events due to fulminant hepatic failure or its sequelae. (See Table 1.)

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The following clinical events are sequelae to acute hepatic failure and may be fatal. If these events occur in the setting of acute hepatic failure associated with paracetamol overdose (adults and adolescents: >12 years of age: >7.5 g within 8 hours; children <12 years of age: >150 mg/kg within 8 hours), they are considered expected.
Expected sequelae to acute hepatic failure associated with paracetamol overdose include the following: Bacterial infection, fungal infection, sepsis, coagulopathy, disseminated intravascular coagulation, thrombocytopenia, hypoglycaemia, hypophosphatemia, lactic acidosis, metabolic acidosis, brain oedema, coma (with massive paracetamol overdose or multiple drug overdose), encephalopathy, cardiomyopathy, hypotension, respiratory failure, gastrointestinal haemorrhage, pancreatitis, acute kidney injury, and multiple organ dysfunction syndrome.
Blood and Lymphatic Disorders: Haemolytic anaemia (in patients with glucose-6-phosphate dehydrogenase [G6PD] deficiency): Haemolysis has been reported in patients with G6PD deficiency, with use of paracetamol in overdose.
In the event of overdose, get medical help or contact a Poison Control Center right away.
What to do when the patient have taken more than the recommended dosage: Overdose warning: Taking more than the recommended dose (overdose) may result in liver damage. In case of overdose, get medical help immediately. Quick medical attention is critical for adults as well as for children even if they do not notice any signs or symptoms.
When should the patient consult the doctor: If pain or fever persists or gets worse, or if new symptoms occur, a physician should be consulted.

Hypersensitivity to paracetamol or to any of the ingredients.

Overdose warning: Taking more than the recommended dose (overdose) may result in liver damage. In case of overdose, get medical help immediately. Quick medical attention is critical for adults as well as for children even if they do not notice any signs or symptoms.
Alcohol Warning: Chronic alcohol users should ask their physician whether they should take paracetamol or other pain relievers or fever reducers.
Patients with hepatic disease should consult a physician before use.
Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported very rarely in patients receiving paracetamol. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Do not use with any other product containing paracetamol.
If symptoms persist or get worse, or if new symptoms occur, stop use and consult a physician.
Effects on Ability to Drive or Use Machines: It is not known if paracetamol has an effect on the ability to drive and use machines. Clinical data suggest that paracetamol does not affect neuromuscular performance.

Pregnancy and Lactation: There are no adequate and well-controlled clinical studies in pregnant or breastfeeding women for paracetamol.
When given to the mother in labeled doses, paracetamol crosses the placenta into fetal circulation as early as 30 minutes after ingestion and is effectively metabolized by fetal sulfate conjugation. When taken as directed, paracetamol does not adversely affect the pregnant mother or fetus.
Paracetamol is excreted in breast milk in low concentrations (0.1% to 1.85% of the ingested maternal dose). Maternal ingestion of paracetamol in labeled doses does not present a risk to the nursing infant.
This product should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs the possible risks to the developing fetus/nursing infant. Ask a physician before use if the patient is pregnant or breastfeeding.

Post-marketing Data: Adverse drug reactions identified during post-marketing experience with paracetamol are included in (CCDS) Table 2 and 3. The frequencies are provided according to the following convention: Very common ≥1/10; Common ≥1/100 and <1/10; Uncommon ≥1/1,000 and <1/100; Rare ≥1/10,000 and <1/1,000; Very rare <1/10,000; Not known (cannot be estimated from the available data).
In Table 2, ADRs identified are presented by frequency category based on incidence in adequately designed clinical trials or epidemiology studies, if available or when incidence is unavailable, frequency category is listed as Not known. (See Tables 2 and 3.)

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Use with Warfarin-like Compounds: For most patients, occasional use of paracetamol generally has little or no effect on the INR in patients on chronic warfarin therapy; however, there has been controversy regarding the possibility of paracetamol potentiating the anticoagulant effects of warfarin and other coumarin derivatives. Consumers should be instructed to ask a physician or pharmacist before use if they are taking the blood thinning drug warfarin or other coumarin derivatives.
Flucloxacillin: High anion gap metabolic acidosis from pyroglutamic acid (5-oxoprolinemia) has been reported with concomitant use of therapeutic doses of paracetamol and flucloxacillin. Patients reported to be most at risk are elderly females with underlying disease such as sepsis, renal function abnormality, and malnutrition. Most patients improve after stopping one or both of the drugs. Consumers should be instructed to ask their healthcare provider before use if they are taking the antibiotic flucloxacillin.

Store at temperatures not exceeding 30°C.

Analgesics (Non-Opioid) & Antipyretics

N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.

Non-Rx