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Logo CEPACOL* COUGH LINCTUS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

CEPACOL* COUGH LINCTUS

COMPOSITION:
Each 10 mL contains:
  Dextromethorphan hydrobromide 30 mg
  Doxylamine succinate 6 mg
  Sodium citrate 500 mg
  Cetylpyridinium chloride 2,5 mg
  Alcohol 10 % by volume 
  0,1 % Sodium Benzoate added as preservative 

PHARMACOLOGICAL CLASSIFICATION:
A 10.1 Antitussives and Expectorants.

PHARMACOLOGICAL ACTION:
Dextromethorphan hydrobromide: a non-narcotic antitussive agent which is believed to inhibit the cough reflex by acting on the cough centre in the medulla. It has a relatively long antitussive action lasting from 6-8 hours.
Cetylpyridinium chloride: Laboratory studies show that Cetylpyridinium chloride has a marked bactericidal action against a wide range of bacteria and effective against pathogenic organisms which are associated with sore throats due to colds. It also has anti-fungal properties in laboratory studies. By lowering surface tension (detergent action) it spreads over the oral and pharyngeal mucosal to loosen and desperse bacteria-laden mucus in the mouth and throat.
Doxylamine succinate: is an antihistamine which inhibits histamine-induced bronchospasm. It is useful in the treatment of allergic cough. Doxylamine succinate lessens mucoid secretion and hyperaemia and provides a mild calming effect.
Sodium citrate: is a well recognised expectorant which liquifies thick mucus secretion and facilitates raising of sputum.

INDICATIONS:
Cepacol* Cough Linctus
is recommended for the symptomatic treatment of acute bronchial attacks, tracheo-bronchitis, allergic bronchitis, laryngitis, coughs due to colds (coryza), coughs associated with chronic pulmonary disease and chronic coughs of probable allergic origin.

CONTRA-INDICATIONS:
Sensitivity to any of the components.

DOSAGE AND DIRECTIONS FOR USE:
Adults 12 years and over: Two medicine measuresful (10 mL) every 6 - 8 hours and before retiring.
Children 6 - 12 years: One medicine measureful (5 mL) every 6 - 8 hours and before retiring.
Shake the bottle before use.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The use of this medicine leads to drowsiness which is aggravated by simultaneous intake of alcohol. Gastrointestinal upsets, dizziness and excitation have very occasionally been associated with dextromethorphan therapy. In cases of high fever or persistent cough or where relief is not obtained within three days, consult your doctor.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No reported cases of overdosage have been observed with Cepacol* Cough Linctus. Drowsiness, excitement, stupor and coma related to the anhistaminic effects may be present.
Treatment should include gastric lavage plus supportive therapy.

IDENTIFICATION:
A dark brown syrup.

PRESENTATION:
In amber glass bottles of 100 mL and 200 mL.

STORAGE INSTRUCTIONS:
Store below 25°C and, as with all medications, keep out of reach of children.

REGISTRATION / REFERENCE NUMBER:
Reference Number: G637 (Act 101/1965)

NAME AND ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston, Ext. 77
Private Bag X69
Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
22 MARCH 1979

*CEPACOL is a Registered Trademark.

New addition to this site: April 2004
Source: Pharmaceutical Industry

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