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

Logo Children's TYLENOL Suspension.
SCHEDULING STATUS:
Schedule 1.

PROPRIETARY NAME
(and dosage form):

Children's TYLENOL Suspension.

COMPOSITION
Each 5 mL contains 160 mg paracetamol and sodium benzoate (0,2 "% m/v) and butylparaben (0,025% m/v) as preservatives.

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 Suspension is indicated for the relief of simple pain such as headache, sore throat, toothache, teething and fever or discomfort associated with colds and flu.

CONTRA-INDICATIONS:
Hypersensitivity 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 pain for more than 10 days without consulting a doctor.

DOSAGE AND DIRECTIONS FOR USE:
Do not exceed the stated dosage.
All dosages may be repeated every 4 hours, but not more than 5 times daily. May be given alone or mixed with formula, milk, juices etc.

                FOR BEST RESULTS:
Always follow the chart below for proper dosing. If you have any questions, consult your doctor or pharmacist.
AGE                                 DOSAGE 
          (mL)         (tsp)
3 months -1 year         2,5 - 3,75 mL         ½ - ¾
2 - 6 years         5,0 - 7,5 mL         1 - 1½
6 - 12 years         10,0 -15,0 mL         2 - 3

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Paracetamol may cause pancreatitis, 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, leucopenia, thrombocytopenia and agranulocytosis.

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.
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 IV 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:
A cherry flavoured, red suspension.

PRESENTATION:
Glass or polypropylene bottles containing 100 mL or 28 mL.

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

REGISTRATION NUMBER:
30/2.7/0498

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
JANSSEN - CILAG
JANSSEN PHARMACEUTICA (PTY) LTD (Reg. No. 80/11122/07)
15th Road
HALFWAY HOUSE
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
8 April 1997
                Code No: 023688
                99C
                Britepak

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