OUTER LABELLING
CARDBOARD BOX
Lime flower
Tiliae flos
Composition:
Lime flower (Tiliae flos) – 2.0 g
Herbs for brewing in sachets, 2.0 g per sachet
30 sachets, 2.0 g each
EAN UCC: 5909990220120
Indications for use:
As an antipyretic and diaphoretic in the common cold.
Method of administration: Oral.
Posology: Adults and adolescents over 12 years: 1 sachet, pour boiling water and brew covered for 15 minutes. Treatment should be started at the first symptoms of a cold.
Contraindications:
Hypersensitivity to lime flower. Due to the lack of safety data, do not give to children under 12 years.
Warnings and precautions:
If during use symptoms worsen or there occur shortness of breath, high fever or purulent sputum, consult a doctor or other qualified medical professional.
If the symptoms worsen or do not subside after 1 week, consult a doctor.
Interactions:
Unknown.
Pregnancy and lactation:
Due to lack of safety data, not recommended for use during pregnancy and lactation.
Impact on ability to drive vehicles and operate machinery:
None.
Adverse effects:
Unknown.
Reporting adverse effects:
In case of any adverse effect, including those not stated on the packaging, notify a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Adverse Drug Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl.
Adverse effects can also be reported to the marketing authorisation holder. Reporting adverse effects allows for more safety information to be gathered on a medicinal product.
Overdose:
None observed.
Dose omission:
Do not use double doses to supplement omitted doses.
Storage:
Store closed in max. 30 °C.
Keep away from children.
Marketing authorisation holder:
- Labofarm Sp. z o.o.
ul. Lubichowska 176 b
83-200 Starogard Gdański
tel. 58 561 20 08
e-mail: poczta@labofarm.com.pl
Marketing authorisation number: 11463.
Batch number:
Expiry date:
Do not use after expiry date.
Non-prescription medicinal product – OTC
Date of information approval: 2016.08.29