Expectorant Cough Syrup
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Expectorant Cough Syrup
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
INGREDIENT
QTY UNIT
200 mg
Guaifenesin
DOSE 15ml
3. PHARMACEUTICAL FORM
Liquid
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
To loosen stubborn mucus and clear chesty coughs.
4.2. Posology and Method of Administration
Adults, the Elderly and Children 12 years and over: 15 ml in dosing cup provided.
The dose should not be repeated more frequently than every 6 hours.
Not more than 3 doses should be taken in any 24 hours. Do not exceed the stated dose.
This product is contraindicated in children under the age of 12 years (see section 4.3).
Do not take with any other cough and cold medicine.
Contraindications
4.3.
Known hypersensitivity to any of the ingredients - Porphyria.
Not to be used in children under the age of 12 years.
4.4. Special Warnings and Special Precautions for Use
Keep out of the reach of children.
If symptoms persist consult your doctor.
4.5. Interaction with other Medicinal Products and other Forms of Interaction
None reported.
4.6. Pregnancy and Lactation
Use in pregnancy and lactation not contra-indicated.
4.7. Effects on Ability to Drive and Use Machines
None stated.
4.8 Undesirable effects
Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as: Very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to <1/100), rare (>1/10,000 to<1/1000) and very rare (<1/10,000), not known (cannot be estimated from the available data)
Immune system disorders
Unknown: hypersensitivity reactions
Gastrointestinal disorders
Unknown: Abdominal discomfort, nausea and vomiting 4.9. Overdose
Very large doses of Guaifenesin can cause nausea and vomiting.
Vomiting should be treated by fluid replacement and monitoring of electrolytes.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Mechanism of action/effect
Guaifenesin is a well known expectorant. Such expectorants are known to increase the volume of secretions in the respiratory tract and therefore to facilitate their removal by cilary action and coughing.
5.2. Pharmacokinetic Properties
Absorption and Fate:
Guaifenesin is absorbed from the gastro-intestinal tract. It is metabolised and excreted in the urine.
5.3. Pre-clinical Safety Data
Not applicable.
6. PHARMACEUTICAL PROPERTIES
6.1. List of Excipients
Glycerin BP
Sorbitol 70% Solution Non-Crystallising EP
Sodium Cyclamate EP
Sodium Saccharin EP
Carrageenan
Flavour Mix
Potassium Sorbate BP
Ponceau 4R E124
Caramel E150
Purified Water BP
6.2. Incompatibilities
None.
6.3. Shelf-Life
Three years.
6.4. Special Precautions for Storage
Do not store above 25°C.
6.5. Nature and Content of Container
Amber glass bottles with polypropylene/polythene caps containing 150 ml of product.
6.6. Instructions for Use, Handling and Disposal
Shake well before use.
7. MARKETING AUTHORISATION HOLDER
Wrafton Laboratories Limited
Wrafton
Braunton
North Devon
EX33 2DL
8. MARKETING AUTHORISATION NUMBER(S)
PL 12063/0021
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/08/2007
10
DATE OF REVISION OF THE TEXT
22/05/2013