PHARMACOLOGICAL CLASSIFICATION: 10.1 Antitussives and Expectorants.
PHARMACOLOGICAL ACTION: Diphenhydramine Hydrochloride is a competative antagonist of histamine with a bronchodilating and decongestant effect of the bronchial mucus membranes. Diphenhydramine also has a sedative effect. Pholcodine is a cough suppressant with mild sedative and analgesic effects. Glyceryl Guaiacolate is an effective expectorant.
INDICATIONS: For the relief of cough.
CONTRA-INDICATIONS: Not to be used in epileptics, in patients with renal hepatic or cardiovascular disease, diabetes militus 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. While taking the medicine patients should not drive a motor vehicle or operate dangerous machinery.
DOSAGE AND DIRECTIONS FOR USE: Adults: 5 - 10 mL every 2 to 3 hours or as prescribed.
Children: 2,5 - 5,0 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, colic and epigastric pain. Antihistamines may also produce headache, blurred vision, tinnitus, irritability, anorexia, 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 infants and children. The symptoms are convulsions, hyperpyrexia, ataxia and confusion. Vomiting is often absent. Death may occur from respiratory depression. Treatment is symptomatic.
CONDITIONS OF REGISTRATION: None.
IDENTIFICATION: A brown-coloured syrup.
PRESENTATION: Amber glass bottels with 100 mL and 200 mL.
STORAGE INSTRUCTIONS: Store in a dry place below 25°C. Protect from light.
Keep out of reach of children.
REGISTRATION NUMBER: Q/10.1/243
NAME AND BUSINESS ADDRESS OF APPLICANT: Columbia Pharmaceuticals (Pty) Ltd