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

Logo ‘ORNACOL’Liquid

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

‘ORNACOL’Liquid

COMPOSITION’
Each 5 mL contains
Dextromethorphan hydrobromide 15 mg and Phenylpropanolamine hydrochloride 12,5 mg
Preserved with methyl hydroxybenzoate 3,125 mg and propyl hydroxybenzoate 0,625 mg per 5 mL
Contains ethyl alcohol 8 % v/v

PHARMACOLOGICAL CLASSIFICATION:
A 10.1 (Antitussives and expectorants)

PHARMACOLOGICAL ACTION:
‘Ornacol’is specifically formulated for temporary relief from coughing and nasal congestion associated with the common cold and sinusitis.

‘Ornacol’contains no sedatives or antihistamines and therefore does not produce drowsiness in most patients. This makes it particularly suited for working patients and others who must remain alert.

‘Ornacol’contains dextromethorphan hydrobromide, a synthetic, non-narcotic cough suppressant with efficacy equal to that of codeine but with particularly low incidence of adverse reactions.

‘Ornacol’contains phenylpropanolamine hydrochloride, which provides vasoconstriction similar to that of ephedrine but with less CNS stimulation.

INDICATIONS:
Temporary relief from coughing and nasal congestion associated with the common cold, sinusitis, and upper respiratory tract infections.

CONTRA-INDICATIONS:
As with any product containing a sympathomimetic ‘Ornacol’should not be used in patients lacking MAO inhibitors or within about ten days of discontinuation of such treatment.

WARNINGS:
Use with caution in persons with hypertension, heart disease, thyroid disease or diabetes.

DOSAGE AND DIRECTIONS FOR USE:
Adults and Children over 12 years:
10 mL (two medicine measurefuls) 4 times a day.

Children 4 - 12 years:
5 mL (one medicine measureful) 4 times a day.

Children 2 - 4 years:
2,5 mL (one half medicine measureful) 4 times a day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Adverse reactions are mild and infrequent as with the individual ingredients, and may include drowsiness, headache, insomnia, nausea, rash and vertigo

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No cases of overdosage with ‘Ornacol’have been reported, but it is likely that symptoms would be those of the individual components.

Symptoms: May include rapid pulse and respiration, disorientation, elevated blood pressure, tachycardia, dilated pupils, headache, excitation of the CNS, nausea and vomiting, gastro-intestinal upset, and anorexia.

Treatment: Treatment is essentially symptomatic. Immediate evacuation of the stomach should be induced through emesis and gastric lavage. If marked excitement is present, one of the short-acting barbiturates or chloral hydrate may be used.

CONDITIONS OF REGISTRATION:
None

IDENTIFICATION:
A clear red viscous liquid with a cherry/strawberry flavour and chloroform overtones.

PRESENTATION:
Supplied in 100 mL glass bottles.

STORAGE INSTRUCTIONS:
Store at room temperature below 25°C.
Keep out of reach of children.

REGISTRATION NUMBER:
‘Ornacol’Liquid
Reg. No. G/10.1/81

APPLICANT:
Smith Kline & French (Pty) Limited
Reg. No. 05/02856/07
Isando Road, Isando, Transvaal

DATE OF PUBLICATION:
25.09.1974

Durbow R23758 Code 0196 Spec 0988

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