FTPR 08

cough syrup
MDR MEDICAL DEVICE CE

REFERENCE: FTPR 08 – CE 0373

Medical Device (class IIa) for the treatment of dry and wet cough.

Properties: Medical Device based on natural extratcs and honey, it creates a mucoadhesive film that calms the cough protecting the upper respiratory tract. Useful in case of dry and productive cough, it calms the irritation, protecting the mucosa and favouring the removal of mucus. It also promotes the hydration of the mucosa and the mucus, favouring its expulsion. The particular formulation rich in mucilages protects the mucosa from irritation. Honey, present in the formulation, carries out a protective and emollient action giving the syrup a taste appreciated by the children.
Medical device promotes, with mechanical action mode, the protection and hydration of the pharyngeal mucosa.
In case of productive cough promoting the hydration of the mucus it favors its expulsion.
In case of dry cough it protects the pharyngeal mucosa from irritants carrying out soothing action on the irritated mucosa.

Posology and Instructions for use:
• Children 1-2 years: 2,5 ml 2-3 times a day, according to medical opinion
• Children 3-4 years: 5 ml 2-3 times a day
• Children 5-9 years: 10 ml 2-3 times a day

Take preferably between meals.
Shake the bottle before use.

Warnings:
▪ Before administering to children under three years of age, it is recommended that you seek the advice of your doctor.
▪ In children under three years of age, if symptoms persist and worsen after first two days of treatment, consult your doctor.
▪ If you do not notice appreciable results after a short period of treatment (7 days), contact your doctor, in any case do not use for more than 15 days.
▪ Do not take it if you are allergic, intolerant or hypersensitive to any component.
▪ Do not use the product after the expiry date printed on the package.
▪ Keep out of the reach of children.
▪ Do not use for purposes other than that for which the product is intended.
▪ So far, no side effects have been observed as a result of the administration of the device. However, if you notice the appearance of side effects, inform your doctor or pharmacist.
▪ Expiry date refers to the product in its intact packaging, and properly stored.

Report of incidents:
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the Competent Autorithy. In case of any undesired event always seek for medical advice.

Modalità di conservazione:
Conservare nella confezione originale a temperatura ambiente in luogo fresco e asciutto ed al riparo dalla luce.
Il periodo di validità dopo la prima apertura dello sciroppo è di 2 mesi
Non utilizzare nel caso in cui il confezionamento non si presenti integro.

Wash carefully the measuring cup after use.
Close the bottle carefully after use.

Composition: Flower honey, Althaea officinalis L. (root) extract supported by maltodextrins, Hedera helix L. (leaf) extract supported by maltodextrins, Xanthan gum E415, Fructose, Wild strawberry flavour, Potassium sorbate E202, Citric acid E330, Purified water.
One measuring cup containing 2.5 ml of product contains 0,92 g of simple sugars.

Content total SALE: 100 mL ℮ + measuring cup (CE 0373 )
Content total SAMPLE: 15 mL ℮ + measuring cup (CE 0373)

Other Informations:
Glutin Free – Lactose Free – For children from one year of age (1+)

Manufacturer: Labomar S.p.A., Via N. Sauro 35/I, Istrana (TV) Italy.

Revision: October 2022.