INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CHILDREN'S TYLENOL® Chewable Tablets

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

CHILDREN'S TYLENOL® Chewable Tablets

COMPOSITION
Each tablet contains 80 mg
paracetamol.

PHARMACOLOGICAL CLASSIFICATION
A. 2.7 Anti-pyretic or anti-pyretic and anti inflammatory analgesics.

PHARMACOLOGICAL ACTION
Paracetamol has analgesic and antipyretic properties.

INDICATIONS
Children's TYLENOL chewable Tablets are indicated for the temporary relief of simple pain such as headache, sore throat, toothache, teething and fever or discomfort associated with colds and flu.

CONTRA-INDICATIONS
Sensitivity to paracetamol.
Severe liver function impairment.

WARNINGS
Dosages in excess of those recommended may cause severe liver damage. Patients suffering from liver or kidney disease should take paracetamol under medical supervision.
Consult a doctor if no relief is obtained from the recommended dosage. Do not use continuously for more than 10 days without consulting a doctor.

DOSAGE AND DIRECTIONS FOR USE
All dosages may be repeated every 4 hours, but not more than 5 times daily.
Chew tablets before swallowing.

FOR BEST RESULTS:
Always follow the chart below for proper dosing. If you have any questions, consult your doctor or pharmacist.
AGE DOSAGE (tablets)
2–3 Years 2
4–5 Years 3
6–8 Years 4
9–10 Years 5
11 Years 6

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Paracetamol may cause allergic reactions and skin rash. The rash usually appears as red areas or allergic wheals, and may be accompanied by fever and involvement of the mucous membranes. The use of paracetamol has been associated with the occurrence of neutropenia, pancytopenia and leucopenia.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia, and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion.
Abnormalities of glucose metabolism and metabolic acidosis may occur.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported. Symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may become manifest on the second day, (or later) initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy, coma and death. Cerebral oedema and non-specific myocardial depression have also occurred.
In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible.

Information for the doctor
Prompt treatment is essential. Any patient who has ingested about 7,5 g of paracetamol in the preceding 4 hours should undergo gastric lavage.
Specific therapy with an antidote such as acetylcysteine or methionine may be necessary. If decided upon, acetylcysteine should be administered intravenously as soon as possible.
Acetylcysteine:
Acetylcysteine should be administered as soon as possible, preferably within 8 hours of overdosage. Intravenously: An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours, and then 100 mg/kg in 1000 mL over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally: 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses Acetylcysteine is effective if administered within 8 hours of overdosage.

IDENTIFICATION
Round, pink speckled, flat faced tablet, scored on one side and engraved with "TYLENOL" above "80" on the other side, with a fruity odour.

PRESENTATION
Containers with 30 tablets.

STORAGE DIRECTIONS
Store below 25°C. Protect from light and moisture.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER
P/2.7/135

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN - CILAG

JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No.1980/011122/07)
15th Road, HALFWAY HOUSE, 1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
14 October 1982

® Trademark
                Code No.: 024026
                        2000J
                        Britepak

Updated on this site: January 2001

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