FTPR44

Organization name

Labomar S.p.A.

SRN

IT-MF-000007965

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Before administering to children under three years of age, it is recommended to seek advice from 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. No side effects associated by used the device have been observed. If you notice the appearance of side effects, inform your doctor. Expiry date refers to the product in its intact packaging and properly stored. Since no data on use during pregnancy and lactation are available, its use is generally not recommended as a precaution due to lack of experimental data. Even if no side effects are known, it is recommended not to use the product during pregnancy or breastfeeding. In any case, consult your doctor before taking it. In the event of concomitant pharmacological treatment, although no interactions with drugs are known, it is advisable to consult a doctor before use. Do not exceed the recommended daily dose. Do not use in case the package is not intact. The period of validity after the first opening of the syrup is 6 months. 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.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

08056300621980

Basic UDI-DI

805630062FTPR449L

Reference / catalog number

FTPR44

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

TussControl Pediatric is a medical device composed of substances, not sterile, intended for short term invasive contact with respect to body orifices (oral cavity), designed for the treatment of productive and dry cough in adults and children (1+). Its specific formula creates a mucoadhesive protective film with a barrier effect in the throat. In case of dry cough, TussControl Pediatric calms the cough by protecting the mucosa from irritating agents. In the case of a productive cough, it promotes the hydration of the mucus and facilitates its physiological expectoration. The product can be used as coadjuvant for the treatment of dry and productive cough.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES