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

Logo BENYLIN DRY COUGH

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

BENYLIN DRY COUGH
(syrup)

COMPOSITION:
Each 5 mL syrup contains:
Dextromethorphan hydrobromide         15 mg
Preservative: Sodium Benzoate         0,5% m/v
Sugar-free        Alcohol-free

PHARMACOLOGICAL CLASSIFICATION:
A: 10.1 Antitussives and Expectorants

PHARMACOLOGICAL ACTION:
Dextromethorphan is a centrally acting cough suppressant. It acts by elevating the threshold for coughing.

INDICATIONS:
Benylin Dry Cough is indicated for the symptomatic relief of non-productive cough.

CONTRA-INDICATIONS:
Sensitivity to dextromethorphan. Contra-indicated in asthma and hepatic dysfunction.

DOSAGE AND DIRECTIONS FOR USE:
Not to be given to children under 1 year of age.

Adults:                One medicine measure (5 mL) every four hours, or two medicine measures (10 mL) every six to eight hours.
Children 6 to 12 years: Half to one medicine measure (2,5 mL - 5 mL) every six to eight hours.
Children 1 to 6 years: Half medicine measure (2,5 mL) every six to eight hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Dextromethorphan may cause dizziness, gastro-intestinal disturbances, drowsiness, nausea and vomiting, and stomach pain. Respiratory depression is expected to occur at very high doses.
Special Precautions:
Persistant coughs should be investigated by a doctor for the possible underlying cause.
(Drug) Interactions:
Concomitant administration with central nervous system depressants may potentiate central nervous system depressant effects. Concurrent use with monoamine oxidase inhibitors may cause excitation, hypertension and hyperpyrexia.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Excitation and confusion may occur after overdosage.
Treatment:
Symptomatic and supportive.

IDENTIFICATION:
Dark brown syrup with a faint odour of menthol and raspberries.

PRESENTATION:
Bottles containing 100 mL.

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C). Keep out of reach of children.

REGISTRATION NUMBER:
Z/10.1/5.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pfizer Consumer Healthcare, division of
Warner-Lambert S.A. (Pty) Ltd.
241 Main Road,
RETREAT
7945

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
14 October 1991

Zimbabwe:         2000/22.2.5/3769
Botswana:         R9800287
Malawi:         PMPB/PL 48/11
Tanzania:         TAN 00,927 R05F WAR
Uganda:         1651/25/97
Kenya:         H2001/0370
Ghana:         FDB/SD.02-8230

Updated on this site: February 2005
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2005