INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
BENYLIN CHILDREN’S WET COUGH

SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

BENYLIN CHILDREN’S WET COUGH
(Liquid)

COMPOSITION:
Quantity per 10 mL:

	Guaifenesin	100 mg
	Preservative:
	Sodium Benzoate	0,1% m/v

Alcohol free, sugar free and colourant free, with a strawberry odour and taste.

PHARMACOLOGICAL CLASSIFICATION:
A: 10.1 Antitussives and Expectorants.

PHARMACOLOGICAL ACTION:
Guaifenesin has expectorant properties.

INDICATIONS:
Alleviation of cough.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients. Pregnancy and lactation.
Guaifenesin is considered unsafe in patients with acute porphyria.
Not recommended for children under 2 years of age.

WARNINGS:
Guaifenesin should not be taken for persistent cough such as occurs with smoking, asthma, emphysema or where cough is accompanied by excessive secretions except under the advice and supervision of a doctor. A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur or is accompanied by high fever, rash or persistent headache, consult a doctor.

DOSAGE AND DIRECTIONS FOR USE:
Children:

	6–12 years old:	10 mL –20 mL (two –four medicine measures) every 4 hours.
	2–5 years old:	5 mL –10 mL (one - two medicine measures) every 4 hours.

If symptoms persist, a doctor should be consulted.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal discomfort, diarrhoea, dizziness, headache, nausea, vomiting, skin rash, stomach pains, urticaria and drowsiness may occur.
Guaifenesin may interfere with diagnostic measurements of urinary 5-hydroxy-indoleacetic acid or vanillylmandelic acid.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In large doses, guaifenesin will cause drowsiness, nausea and vomiting.
Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear, colourless to straw-coloured, syrupy liquid with a strawberry odour and taste.

PRESENTATION:
Amber glass bottles of 100 mL.

STORAGE INSTRUCTIONS:
Keep well closed and store in a cool place (below 25°C). KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
35/10.1/0266

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
7 March 2003

Updated on this site: February 2005
Source: Pharmaceutical Industry
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