Signs and Symptoms associated with an overdose of Guaifenesin:
Nausea and vomiting
Treatment:
Appropriate supportive therapy dependent upon individual response to the preparation.
100ml bottles: 27 months
250ml bottles: 36 months.
Hypersensitivity to any of the constituents.
Use in children under 12 years.
.
Glycerol
Carmellose Sodium
Sodium Benzoate (E211)
Sodium Cyclamate
Ethanol (96%)
Levomenthol
Maltitol (E965)
Sorbitol Solution 70%
Natural Cherry Flavouring
Citric Acid Anhydrous
Caramel (E150)
Acesulfame Potassium
Purified Water
A deep wine-russet coloured oral solution with a raspberry odour and taste.
The following side effects may be associated with the use of Guaifenesin:
Gastrointestinal Disorders
Nausea, vomiting
Immune System Disorders
Hypersensitivity reactions
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
No relevant information additional to that already contained elsewhere in the SPC.
Expectorant for the treatment of coughs.
Guaifenesin has an expectorant action which increases the output of respiratory tract fluid by reducing adhesiveness and surface tension. The increased flow of less viscid secretions promotes ciliary action and facilitates the removal of mucus. This changes an unproductive cough to a cough that is more productive and less frequent.
Pharmacotherapeutic group: Expectorant
ATC code: RO5CAO3
Guaifenesin is well absorbed from the gastro intestinal tract following oral administration. Guaifenesin has a plasma half-life of approximately 1 hour. It is rapidly hydrolyzed (60% within seven hours) and then excreted in the urine, with beta-(2-methoxyphenoxy)-lactic acid as its major urinary metabolite
January 2014
Robitussin Chesty Cough Medicine
Pfizer Consumer Healthcare Ltd
Ramsgate Road
Sandwich
Kent
CT13 9NJ
United Kingdom
Do not store above 25°C.
Keep out of the sight and reach of children.
PET bottles containing 100ml or 250ml with PET lined PP/HDPE screw caps.
A clear polypropylene measuring cap is also included.
PL 00165/0097
Active Ingredient:
Guaifenesin Ph Eur 100mg per 5ml
Causes of chronic cough should be excluded if symptoms are persistent. Any accompanying symptoms should be actively sought and appropriately investigated/treated. Stop use and ask a healthcare professional if your cough lasts more than 7 days, comes back or is accompanied by a fever, rash, or persistent headache.
Keep out of the sight and reach of children.
Do not exceed recommended dose.
Excipient warnings:
- Patients with rare hereditary problems of fructose intolerance should not take this medicine because this product contains Sorbitol and Maltitol.
- This medicinal product contains 2.7% v/v ethanol (alcohol), up to 214 mg per dose, (equivalent to approx 2 ml wine per dose). Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women and high-risk groups such as patients with liver disease, or epilepsy.
No or negligible influence.
Oral administration.
Adults, the elderly and children over 12 years: One 10ml measure up to four times daily.
Children under12 years: Do not use.
No special requirements
1 September 1993
