INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
FLEMMI-PED COUGH SYRUP [SYRUP]

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

FLEMMI-PED COUGH SYRUP [SYRUP]

COMPOSITION:
Each 5 mL contains:
        Guaiphenesin        25 mg
        Alcohol 96%        5,0% v/v

PRESERVATIVES:
        Methyl hydroxybenzoate        0,09% m/v
        Propyl hydroxybenzoate        0,01% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Antitussives and expectorants.

INDICATIONS:
For the alleviation of coughs in infants and children.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.

DOSAGE AND DIRECTIONS FOR USE:
Infants 6 months-2 years:
        2,5 mL [Half a medicine measureful]
Children 2- 6 years:
        5,0 mL [One medicine measureful]
Children 6-12 years:
        10,0 mL [Two medicine measurefuls]
Every 4 hours when necessary.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal discomfort and drowsiness have been reported. Large doses cause nausea and vomiting. Guaiphenesin may interfere with diagnostic measurements of urinary 5-Hydroxyindoleacetic acid or vanillylmandelic acid.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage are nausea and vomiting.
Treatment is symptomatic and supportive.

IDENTIFICATION:
An orange coloured syrup with an orange flavour and odour.

PRESENTATION:
Glass bottle of 100 mL.

STORAGE INSTRUCTIONS:
Store below 25 °C in a cool place.
KEEP OUT OF THE REACH OF CHILDREN.

REFERENCE NUMBER:
G.693 [Act 101/1965]

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
S.A.D. SELF MEDICATION [PTY] LIMITED
[Co. Reg. No. 92/04769/07]
Robbie de Lange Road, Wilsonia, EAST LONDON 5201

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
December 1989
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