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

Logo BENYLIN WET COUGH
SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

BENYLIN WET COUGH
(Liquid)

COMPOSITION:
Each 10 mL contains:
Guaifenesin         200 mg
Preservative: 
Sodium Benzoate 0,1% m/v
Alcohol free, sugar free and colourant free.

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:
Benylin Wet Cough should not be taken for persistent cough, which 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.

INTERACTIONS:
Guaifenesin may interfere with diagnostic measurements of urinary 5-hydroxy-indoleacetic acid or vanillylmandelic acid.

PREGNANCY AND LACTATION:
Benylin Wet Cough should not be used during pregnancy and lactation.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years: 10 mL - 20 mL (two - four medicine measures) every 4 hours.
Children 6 - 12 years old: 5 mL - 10 mL (one - two medicine measures) every 4 hours.
        2 - 5 years old: 2,5 mL - 5 mL (half - one medicine measure) every 4 hours.
If symptoms persist a doctor should be consulted.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Rare (>1/10 000, < 1/1 000):
Gastro-intestinal: Diarrhoea, nausea, vomiting, stomach pains.
Central Nervous System: Headache, drowsiness, dizziness.
Skin: Skin rash, urticaria.

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 50 mL, 100 mL and 200 mL.

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

REGISTRATION NUMBER:
37/10.1/0061

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
17 September 2004

New addition to this site: February 2005
Source: Pharmaceutical Industry

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