Summary of Product Characteristics (SmPC) - Strepsils Herbal dry Cough & Sore Throat syrup
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Herbal Dry Cough & Sore Throat Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml dose (corresponding to 12 g) of the syrup contains 300 mg of extract (as dry extract) of Ribwort plantain leaf (Plantago lanceolata L. folium) (DER3-5:1).
Extraction solvent: ethanol 20 % (m/m).
Excipient with known effect: Each dose (10 ml) contains 6640 mg maltitol liquid (containing maltitol and up to 450 mg sorbitol).
Each dose (10 ml) contains 78.5 mg of alcohol (ethanol)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
Brown, opaque liquid with characteristic odour
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used to relieve a sore throat and associated dry cough based on traditional use only.
4.2 Posology and method of administration
Posology
Adults, elderly and children aged 12 years and over:
The recommended dose is 10 ml of syrup three to four times a day using the graduated measuring spoon provided.
Children under 12 years of age
The use in children under 12 years of age is not recommended (see section 4.4 Special warnings and precautions for use).
Patients with renal and/or hepatic impairment
Due to the lack of pharmacokinetic data in these patient groups, a dose recommendation is not possible. Patients are advised to consult their doctor or qualified healthcare practitioner before taking Strepsils Herbal Dry Cough & Sore Throat Syrup.
Method of administration
Oral use.
For correct dosing the enclosed measuring spoon should be used, using the relevant graduation marks 2.5 and 5 ml.
The bottle must be shaken well before each use. A sediment may occur during storage. This does not affect the quality of the product.
Duration of use
The recommended dose should not be exceeded. If the symptoms worsen, or persist longer than 7 days during the use of the medicinal product, a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active substance, or to ribwort plantain pollen or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
If dyspnoea, fever or purulent sputum occurs during the use of the medicinal product, a doctor should be consulted.
Paediatric Population The use in children under 12 years of age is not recommended because of concerns requiring medical advice and due to the lack of adequate data.
Strepsils Herbal Dry Cough & Sore Throat Syrup contains maltitol liquid (containing maltitol and sorbitol). May have a mild laxative effect. Calorific value 2.3 kcal/g of maltitol liquid.
This medicine contains up to 450 mg sorbitol in each 10 ml dose which is equivalent to 45 mg/ml. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
Strepsils Herbal Dry Cough & Sore Throat Syrup contains ethanol (alcohol)
This medicine contains 78.5 mg of alcohol (ethanol) in each dosage unit which is equivalent to 7.85 mg/ml (0.785 % (w/v)). The amount in 10 ml of this medicine is equivalent to less than 2 ml beer or 1 ml wine.
The small amount of alcohol in this medicine will not have any noticeable effects.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. However, no drug interactions have been reported.
4.6 Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
Fertility
There are no data on the effects on fertility available.
4.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
4.8 Undesirable effects
None known.
If adverse reactions occur, a doctor or a pharmacist should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after registration of the traditional herbal medicinal product is important. It allows continued monitoring of the safety of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card Scheme at ww.mhra.gov.uk/yellowcard or search for MHRA in the Google Play or Apple App store.
4.9 Overdose
Overdose
No case of overdose has been reported. In the unlikely event of an overdose, serious side effects are not expected.
Management
Consult a healthcare professional. Treatment should be symptomatic and supportive.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC.
5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC.
5.3 Preclinical safety data
The non-clinical data on dry extract from Plantago lanceolata L., folium, are incomplete. Due to its properties as a traditionally used medicinal product, there is sufficient evidence of safe use in humans.
Reverse mutation assays (Ames test) on bacteria indicated that the herbal preparation was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 102, TA 1535 and TA 1537) mutation assays with or without metabolic activation.
Studies on reproductive toxicity and carcinogenicity have not been performed. There is further no information of relevance to the safety assessment in addition to what is stated in other parts of the SmPC (see section 4.6 and 4.9).
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maltodextrin
Maltitol liquid (E 965) (including maltitol and sorbitol)
Xanthan gum (E 415)
Potassium sorbate
Citric acid (for pH adjustment)
Natural flavour Honey-Lemon-Verbena (flavouring preparations, natural flavouring substances, ethanol)
Purified water
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
Originally sealed package: 3 years.
After first opening: 3 months.
6.4 Special precautions for storage
This medicinal product does not require any special temperature storage conditions before opening.
Store below 25°C after first opening.
The bottle must be shaken well before each use. A sediment may occur during storage. This does not affect the quality of the product.
Store in the original container.
6.5 Nature and contents of container
Amber glass bottles with white polyethylene screw cap.
The bottles are packed in a carton with a polypropylene measuring spoon with graduations of 2.5 ml and 5 ml.
Pack size 100 ml and 200 ml
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal.
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
103 – 105 Bath Road
Slough
SL1 3UH
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
THR 00063/0368
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23/02/2026
10 DATE OF REVISION OF THE TEXT
23/02/2026