INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
FLUTEX COUGH MIXTURE ORANGE (SYRUP)

SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

FLUTEX COUGH MIXTURE ORANGE (SYRUP)

COMPOSITION:
Each 5 mL contains:

Guaiphenesin	100 mg
Sodium benzoate	0,1% m/v

SUGAR FREE
ALCOHOL FREE

PHARMACOLOGICAL CLASSIFICATION
A 10.1 Antitussives and expectorants

PHARMACOLOGICAL ACTION
Guaiphenesin is an expectorant that increases the volume and reduces the viscosity of tenacious sputum.
Pharmacokinetics:
Guaiphenesin is absorbed from the gastro-intestinal tract. It is metabolised and excreted in the urine.

INDICATIONS:
Alleviation of cough associated with viscous/tenacious phlegm.

CONTRA-INDICATIONS

-	Hypersensitivity to any of the ingredients.
-	Pregnancy and Lactation.
-	Not recommended for children under 2 years of age.
-	Porphyria.

WARNINGS

•	Do not take for persistent cough such as that 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 medical practitioner.

INTERACTIONS
Interferes with urine tests for 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid.

PREGNANCY AND LACTATION
Safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children 12 years and over: 200 mg-400 mg (10 to 20 mL) orally, every 4 hours. Do not exceed 2400 mg (120 mL) in 24 hours.
6 to 12 years: 100 mg-200 mg (5 to 10 mL) orally every 4 hours. Do not exceed 1200 mg (60 mL) in 24 hours.
2 to 6 years: 50 mg-100 mg orally every 4 hours. Do not exceed 600 mg (30 mL) in 24 hours, or as directed by a medical practitioner.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side effects:
Gastro-intestinal
Less frequent: diarrhoea, nausea, vomiting, stomach pains
Has been reported but frequency is unknown: discomfort
Central Nervous System
Less frequent: headache, dizziness
Has been reported but frequency is unknown: drowsiness
Skin
Less frequent: rash, urticaria

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
(See side effects)
Treatment is symptomatic and supportive.

IDENTIFICATION:
FLUTEX COUGH MIXTURE ORANGE: A clear, orange, slightly viscous liquid.

PRESENTATION
Amber glass bottles in 100 mL.

STORAGE INSTRUCTIONS
Store below 25°C in tightly closed container.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
A38/10.1/0359

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE REGISTRATION CERTIFICATE
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Sandton
2148

DATE OF PUBLICATION OF PACKAGE INSERT
19 April 2006

575156/060821
PINETOWN PRINTERS

New addition to this site: January 2008
Source: Pharmaceutical Industry

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