(and dosage form):
Each 5 mL of syrup contains:
Diphenhydramine Hydrochloride 15 mg
Pholcodine 8 mg
Glyceryl Guaicolate (Guaiphenesin) 100 mg
Methyl Paraben 0,2% m/v
Propyl Paraben 0,02% m/v
Alcohol content 22% v/v
A 10.1 Antitussives and Expectorants
For the relief of cough.
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.
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.
A brown-coloured syrup.
Bottles of 100 mL and 200 mL.
Store in a cool place (below 25°C). Protect from light.
Keep out of reach of children.
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:
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