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

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME
(and dosage form):

FRESHBURST LISTERINE
(Solution).

COMPOSITION:
Per 20 mL:

	Thymol	12,780 mg
	Alcohol (95%)	4,540 mL

Contains Sodium Benzoate and Benzoic Acid

PHARMACOLOGICAL CLASSIFICATION:
A: 16.4 Naso-bucco-pharyngeal antiseptics.

PHARMACOLOGICAL ACTION:
Bacteriostatic antiseptic.

INDICATIONS:
Mild infections of the mouth and throat and associated bad breath. Gingivitis and the control of plaque.

CONTRA-INDICATIONS:
Sensitivity to any of the ingredients. Do not administer to children.

DOSAGE AND DIRECTIONS FOR USE:
Use 20 mL (approximately 3/4 capful); rinse the teeth and gums and gargle for 15 to 30 seconds twice daily. Do not swallow.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
None observed.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
If large quantities are swallowed the toxic effects include:
Thymol:
Extensive local corrosion, with pain, nausea, vomiting, sweating, and diarrhoea.
Alcohol:
Depression of cortical function causing loss of judgement, emotional lability, muscle inco-ordination, visual impairment, slurred speech, and ataxia. Hangover effects may include nausea, headache, dizziness, and tremor.
Treatment:
Contact a doctor. Empty the stomach by aspiration and lavage, taking care to avoid perforation. Castor oil or olive oil may be added to the water to dissolve thymol and delay absorption; 50 mL of oil may be left in the stomach. Keep the patient warm and treat pulmonary oedema, systemic acidosis, respiratory failure, and circulatory failure symptomatically. Respiration may have to be assisted. Haemodialysis is of value in severe alcoholic poisoning.

IDENTIFICATION:
A clear green mint-flavoured solution.

PRESENTATION:
Plastic bottles of 200 mL or 250 mL and 400 mL or 500 mL.

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C) place, away from direct sunlight. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
33/16.4/0319

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:
24 September 1999

Revised: Dec99

Updated on this site: February 2005
Source: Pharmaceutical Industry
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