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

Logo FOLCOFEN SYRUP
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

FOLCOFEN SYRUP

COMPOSITION:
Each 5 mL of syrup contains:
        Diphenhydramine Hydrochloride        15 mg
        Pholcodine        8 mg
        Glyceryl Guaicolate (Guaiphenesin)        100 mg
Preservatives:
        Methyl Paraben        0,2% m/v
        Propyl Paraben        0,02% m/v
        Alcohol content        22% v/v

PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Antitussives and Expectorants

INDICATIONS:
For the relief of cough.

CONTRA-INDICATIONS:
Not to be used in epileptics, in patients with renal, hepatic or cardiovascular disease, diabetes mellitus or severe anaemia. To be used cautiously in patients with cardiac oedema, or in patients sensitive to any of the ingredients.

WARNINGS:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents.

DOSAGE AND DIRECTIONS FOR USE:
ADULTS: 5 to 10 mL every 2 to 3 hours or as prescribed.
CHILDREN: 2,5 to 5 mL every 3 hours or as prescribed.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most common side effect of the antihistamine is varying degrees of sedation. Other side-effects include gastro-intestinal disturbances such as nausea, vomiting, diarrhoea and epigastric pain. Antihistamines may also produce headache, blurred vision, tinnitus, irritability, anorexia and dryness of mouth, difficulty in micturition, allergic reactions and blood dyscrasias.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may result in antihistamine poisoning, especially in infants and children. The symptoms are convulsions, hyperpyrexia, ataxia and confusion. Death may occur from respiratory depression. Treatment is symptomatic.

IDENTIFICATION:
A brown-coloured syrup.

PRESENTATION:
Bottles of 100 mL and 200 mL.

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C). Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER:
N/10.1/99

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
GEO SCHWULST LABS. LIMITED
Co. Reg. No. 77/3056/06
17 Faraday Str,
Village Main, Jhb

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
July 1994

PMO5 15/7/94

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