Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Sad-otc
INDICATIONS [/za_1068.html#1] [/za_1068.html#1] [/za_1068.html#1] CONTRA-INDICATIONS [/za_1068.html#1] [/za_1068.html#1] DOSAGE [/za_1068.html#1] [/za_1068.html#1] SIDE-EFFECTS [/za_1068.html#1] [/za_1068.html#1] PREGNANCY [/za_1068.html#1] OVERDOSE [/za_1068.html#1] IDENTIFICATION [/za_1068.html#1] [/za_1068.html#1] 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 RE Read the complete document