Summary of Product Characteristics Updated 26-Oct-2020 | Thornton & Ross Ltd
Simple Linctus Paediatric
Citric Acid Monohydrate 31.25mg/5ml dose.
Excipient(s) with known effect:
Sucrose (Syrup) 4.4g/5ml dose
Sodium Benzoate(E211) 2.5mg/5ml dose
For the full list of excipients, see section 6.1
For relief of non productive (dry) coughs
1 to 5 years: Give one 5ml spoonful
6 to 12 years: Give two 5ml spoonfuls
Repeat up to four times a day if necessary.
Known hypersensitivity to any of the ingredients
Keep out of the sight and reach of children.
Consult a doctor if symptoms persist for more than 5 days
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicine contains 4.4g of sucrose per 5ml. This should be taken into account in patients with diabetes mellitus.
This medicine contains 2.5mg sodium benzoate per 5ml dose.
This medicine contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially 'sodium-free'.
There are no or limited amount of data from the use of citric acid monohydrate in pregnant women.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
There is insufficient information on the excretion of citric acid monohydrate metabolites in human milk.
Tabulated list of adverse reaction(s)
Adverse reactions frequency are defined using the following convention:
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
System organ class (MedDRA)
Immune System Disorders
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
Overdose with this preparation is unlikely to occur due to the low concentrations of the ingredients. However, in the event treatment should be symptomatic.
Pharmacotherapeutic Group: Acid Preparations
ATC Code: A09 AB
Citric acid is absorbed after oral administration. It is found naturally in the body and is widely distributed. It is metabolised to carbon dioxide and water in Kreb's citric acid cycle. Citric acid is normally excreted in the urine in amounts ranging from 0.4 to 1.5g daily and this amount is not increased unless very large doses are administered.
No data of relevance, which is additional to that included on other sections of the SPC.
Anise flavour (contains propylene glycol (E1520))
Sodium benzoate (E211)
36 months unopened, 3 months after first opening
Store below 25°C
200ml: Amber glass bottle with a white 28mm child resistant cap with tamper evident band and EPE/Saranex liner
Any unused product or waste material should be disposed of in accordance with local requirements.
Thornton & Ross Ltd.
16/06/1988 / 09/09/1993
Linthwaite, Huddersfield, West Yorks, HD7 5QH
+44 (0) 1484 848164