A traditional herbal medicinal product used to relieve the symptoms of nasal catarrh and catarrh of the throat based on traditional use only.

For oral use only.

Adults and the Elderly: One 5ml spoonful three times a day.

The use in children and adolescents under 18 years of age is not recommended (see section 4.4 “ Special warnings and precautions for use” ).

Duration of use:

Do not use for more than one week.

Hypersensitivity to the active substances, other plants of the Asteraceae (Compositae) family or to any of the excipients.

Do not exceed the stated dose.

This medicinal product contains 11.5vol% ethanol (alcohol), i.e. up to 453 mg per dose, equivalent to 12 ml beer, 5 ml wine per dose.

Harmful for those suffering from alcoholism.

To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

This medicinal product contains 3.75 mg dextrose (glucose). Patients with rare glucose-galactose malabsorption should not take this medicine.

This medicinal product contains methyl and propyl hydroxybenzoates and may cause allergic reactions (possibly delayed).

The use in children and adolescents under 18 years of age is not recommended due to lack of adequate data and the alcohol content.

If symptoms worsen or persist for more than one week, a doctor or a qualified healthcare practitioner should be consulted.

If dyspnoea, fever or purulent sputum occurs, a doctor or a qualified healthcare practitioner should be consulted.

Contains alcohol and should therefore be avoided in patients taking other medication known to interact with alcohol e.g. Metronidazole.

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Studies on fertility have not been performed.

No studies on the effect on the ability to drive or operate machines have been performed.

This product contains alcohol (see section 2).

Anaphylactic shock has been reported with Burdock root. The frequency is not known.

If other adverse reactions not mentioned occur, a doctor or a qualified healthcare practitioner should be consulted.

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 cases known.

Overdose of this product may result in alcohol intoxication. The amount of alcohol in a full bottle (9.06gm in 100ml; 13.59gm in 150ml equivalent to 0.4 and 0.6 large glasses of wine, respectively) may result in alcohol intoxication and should be treated accordingly.

Not required as per article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Not required as per article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

Ethanol

Caramel (E150)

Glycerol (E422)

Propyl parahydroxybenzoate

Methyl parahydroxybenzoate (E218)

Capsicum Tincture (containing capsicum oleoresin, ethanol and water)

Viscarin SD 389 (contains dextrose/carageenan (E407)

Menthol

Sodium saccharin (E954)

Purified water.

None known.

Three years unopened.

Once opened use within 28 days.

Do not store above 25 ° C.

100ml amber glass sirop bottle with 28mm polypropylene white tamper-evident cap with EPE/Aluminium/Melinex liner.

150ml amber glass bottle with a 28mm polypropylene white tamper evident cap with EPE/Aluminium/Melinex liner.

150ml amber glass bottle embossed “ Covonia” with a 28mm polypropylene white tamper evident cap with EPE/Aluminium/Melinex liner.

Not all packs may be marketed.

There are no special precautions for disposal.