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

Logo Infants' TYLENOL® drops
SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

Infants' TYLENOL® drops

COMPOSITION
Each 0,8 mL contains 80 mg paracetamol, butylparaben 0,05% m/v as preservative.

PHARMACOLOGICAL CLASSIFICATION
A. 2.7 Antipyretic or antipyretic and anti-inflammatory analgesics.

PHARMACOLOGICAL ACTION
Paracetamol has analgesic and antipyretic properties.

INDICATIONS
Paracetamol is 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
Note: Below the age of 3 months, the dosage is based on body weight: 0,1 mL per kg body weight.
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
        Below 3 months         10 mg (0,1 mL) per kg body weight
        3 months –1 year         (0,8 mL –1,2 mL) 1 –1½ Droppersful
        1 –2 years         (1,2 mL –1,6 mL) 1½ – 2 Droppersful
        2 –3 years         (1,6 mL) 2 Droppersful
Instructions for use:
The bottle comes with a child-proof cap and in-usedropper. To use, do the following:
{illustrated}
1. Push the plastic screw cap down
2. While pressing down, turn the cap counter dockwise.
3. Use the point of the dropper to puncture safety seal.
4. To use enclosed dropper, fill to prescribed level.
Dispense lìquid slowly into the child's mouth, towards inner cheek.
5. Reseal bottle with dropper.

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 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
Fruit flavoured, clear orange liquid, with dropper.

PRESENTATION
Bottles containing 15 mL with an in-use dropper.

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

REGISTRATION NUMBER
P/2.7/137

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
14 October 1982

                        Code No.: 023612
                                                98F
                                        Britepak
® = TRADEMARK       

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