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

Logo PARADCO SYRUP

SCHEDULING STATUS:
Unscheduled

PROPRIETARY NAME
(and dosage form):

PARADCO SYRUP

COMPOSITION:
Each 5 mL contains:
Paracetamol 120 mg
Methyl-p-hydroxybenzoate 0,1% m/v
Alcohol 12,8%, v/v

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Non-narcotic analgesics, antipyretics.

PHARMACOLOGICAL ACTION:
Paracetamol has analgesic and antipyretic actions (Goodman and Gilman 5th edition).

INDICATIONS:
For the relief of mild to moderate pain and fever.

CONTRA-INDICATIONS:
Hypersensitivity to paracetamol.

WARNINGS:
Dosages in excess of those recommended may cause severe liver damage.
This product contains FD & C yellow No. 5 (Tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of Tartrazine sensitivity in the general population is currently thought to be low it is frequently seen in patients who also have aspirin sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
Children (up to 1 year) 2,5 mL to 5,0 mL
Children (1 to 5 years) 5,0 mL to 10,0 mL
Children (6 to 12 years) 10,0 mL to 20,0 mL
Adults   20,0 mL to 40,0 mL
Repeat dosage 4 hourly if necessary but not more than 4 doses in 24 hours.
Do not use continuously for more than 10 days without consulting your doctor.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
(a) SIDE-EFFECTS: usually mild although haematological reactions have been reported. Skin eruptions have also occurred.
(b) SPECIAL PRECAUTIONS:
  1) Patients suffering from liver disease should take Paracetamol under medical supervision.
  2) Keep out of reach of children,
  3) Consult your doctor if no relief is obtained with the recommended dosage.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage include vomiting, gastro-intestinal haemorrhage, liver damage (may only appear after a few days), cerebral oedema and renal tubular necrosis. Kidney failure has been described following acute intoxication. In the event of overdosage consult a doctor or take patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. The latest information regarding the treatment of overdosage can be obtained from the nearest poison centre.

IDENTIFICATION:
A clear dark green syrup with a bitter-sweet and minty taste.

PRESENTATION:
Bottles of 100 mL PVC, 2,5 L plastic bottles and 20 L carbuoys.

STORAGE INSTRUCTIONS:
Store below 30°C out of direct sunlight.
Keep out of reach of children.

REGISTRATION NUMBER:
F/2.8/256

NAME AND BUSINESS ADDRESS OF APPLICANT:
ADCO DRUG CO. (PTY) LTD.,
491 Sydney Road
Durban
4001

DATE OF PUBLICATION OF THIS PACKAGE INSERT

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