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

Logo DIPHENHYDRAMINE EXPECTORANT SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

DIPHENHYDRAMINE EXPECTORANT SYRUP

COMPOSITION:
Each 5 mL contains:
Diphenhydramine Hydrochloride 14,0 mg
Ammonium Chloride 170,0 mg
Sodium Citrate 57,0 mg
Chloroform 0,03 mL
Alcohol 10,69% v/v
Nipasept 0,1% m/v
PHARMACOLOGICAL CLASSIFICATION:
10.1 –Antitussives and Expectorants.

PHARMACOLOGICAL ACTION:
Ammonium Chloride exerts an expectorant action by irritating the gastric mucous membranes.

INDICATIONS:
Alleviation of cough.

CONTRA-INDICATIONS:
Known hypersensitivity to Diphenhydramine hydrochloride, Ammonium chloride is contra-indicated in presence of impaired hepatic or renal function.

WARNINGS:
Persistent coughs should be investigated for the possible underlying cause by a doctor. Use of this medicine may lead to drowsiness and impaired concentration (care must be taken if driving or using potentially, dangerous machinery). This is aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents.

DOSAGE:
Children: 2,5 - 5,0 mL every four hours.
Adults: 5,0 - 10,0 mL every 3 or 4 hours.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Diphenhydramine hydrochloride may cause drowsiness, dry mouth it may potentiate the action of sedatives and tranquillisers and should not be used with monoamine oxidase inhibitors.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage of Diphenhydramine hydrochloride varies in reaction from central nervous depression (mainly in adults) to stimulation which is particularly likely in children. Atropine-like signs and symptoms may also occur. Overdosage of Ammonium chloride may cause nausea, vomiting, acidosis, hypokalaemia.

TREATMENT:
There is no specific therapy for H1 blockers and treatment is along general symptomatic and supportive lines. Acidosis and electrolyte loss may be corrected by i/v administration of Sodium Bicarbonate or Sodium Lactate and hypokalaemia by administration of a suitable potassium salt by mouth.

CONDITIONS OF REGISTRATION:

IDENTIFICATION:
A dark brown syrupy liquid with the odour of chloroform.

PRESENTATION:
100 mL, 2,5 L and 20 L.

STORAGE INSTRUCTIONS:
Keep tightly closed. Store below 30°C out of direct sunlight and out of reach of children.

APPLICATION NUMBER:
G1077 (Wet/Act 101/1965).

NAME AND BUSINESS ADDRESS OF APPLICANT:
ADCO DRUG CO. (PTY) LTD.
491 Sydney Road
Durban 4001.

DATE OF PUBLICATION OF PACKAGE INSERT:
1-3-86.

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