Expectorant herbs – product information

OUTER LABELLING

CARDBOARD BOX

1. PRODUCT NAME

Expectorant herbs

Species expectorantes

• ACTIVE SUBSTANCE CONTENT

Sachet composition:

Thyme herb (Thymi herba) – 0.5 g

Marshmallow leaf (Althaeae folium) – 0.4 g

Aniseed (Anisi fructus) – 0.4 g

Liquorice root (Liquiritiae radix) – 0.4 g

Peppermint leaf (Menthae piperitae folium) – 0.3 g

One sachet contains 2.0 g of herbs, including at least 0.7% of essential oil.

• LIST OF EXCIPIENTS

• PHARMACEUTICAL FORM AND CONTENTS

Herbs for brewing in sachets.

30 sachets, 2.0 g each                                                     EAN UCC: 5909990021994

• METHOD OF ADMINISTRATION

Method of administration: Oral.

Posology: Adults and adolescents over 12 years: 2 sachets, pour boiling water and brew while covered for 15 minutes. Drink a glass of fresh infusion 2 times a day.

• WARNING FOR STORAGE

Keep away from children.

• OTHER SPECIAL WARNINGS (if necessary)

Do not use after expiry date.

Contraindications:

Hypersensitivity to any of the ingredients. Due to to lack of safety data, do not give to children under 12 years old.

Warnings and precautions:

Not recommended to exceed stated doses. If symptoms worsen or persist, consult a doctor. In case of dyspnea, fever or purulent sputum, consult a doctor.

Interactions:

May intensify activity of other expectorants, especially those containing saponins.

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:

In rare cases (≥1/10 000 to <1/1000), stomach irritation can occur, in which case use should be discontinued.

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.

• EXPIRY DATA

Expiry date:

• STORAGE CONDITIONS

Storage:

Store closed in max. 25° C.

1. SPECIAL PRECAUTIONS FOR DISPOSAL OF MEDICINAL PRODUCT OR ITS WASTE (if applicable)

1. NAME AND ADDRESS OF MARKETING AUTHORISATION HOLDER

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

1. MARKETING AUTHORISATION NUMBER

Marketing authorisation number: IL-5783/LN

1. BATCH NUMBER

Batch number:

1. GENERAL CLASSIFICATION

Non-prescription medicinal product – OTC

1. INSTRUCTION FOR USE

Indications for use:

For increasing mucus secretion, as an aid in treating wet cough in irritation of the throat mucosa.

1. INFORMATION IN BRAILLE

Expectorant herbs

1. UNIQUE IDENTIFICATION – 2D CODE

Not applicable.

1. UNIQUE IDENTIFICATION – HUMAN READABLE DATA

Not applicable.

1. OTHER

Date of information approval: 2016.08.25