FTPR08

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 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. 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. 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. The period of validity after the first opening of the syrup is 2 months. Do not use in case the package is not intact. 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 Romania; available across 2 countries total.

Trade name

not provided

UDI-DI code

08056300622079

Basic UDI-DI

805630062FTPR089G

Reference / catalog number

FTPR08

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

Dicotuss baby med 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 children (1+). Its specific formula creates a mucoadhesive protective film with a barrier effect in the throat. In case of dry cough, Baby Cough syrup 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 adjuvant 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.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES