Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Thyme herb extract der 7-13:1, extraction medium: water, native; Marshmallow liquid extract der 1:12-14, extraction medium: water, native
Kwizda Pharma GmbH
R05CA; R05CA10
Thyme herb extract der 7-13:1, extraction medium: water, native; Marshmallow liquid extract der 1:12-14, extraction medium: water, native
.
Syrup
Product not subject to medical prescription
Expectorants; combinations
Authorised
2015-03-13
1/5 PACKAGE LEAFLET: INFORMATION FOR THE USER Buttercup Bronchostop Cough Syrup Thyme herb dry extract, Marshmallow root liquid extract Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or qualified Healthcare Professional has told you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. You must talk to a doctor if you do not feel better or if you feel worse after 7 days. What is in this leaflet: 1. What Buttercup Bronchostop® Cough Syrup is and what it is used for 2. What you need to know before you take Buttercup Bronchostop® Cough Syrup 3. How to take Buttercup Bronchostop® Cough Syrup 4. Possible side effects 5. How to store Buttercup Bronchostop® Cough Syrup 6. Contents of the pack and other information 1. WHAT BUTTERCUP BRONCHOSTOP® COUGH SYRUP IS AND WHAT IT IS USED FOR Buttercup Bronchostop® Cough Syrup is a traditional herbal medicinal product used for the relief of coughs, such as chesty, dry, tickly, irritating coughs and catarrh exclusively based on long standing use. Buttercup Bronchostop® Cough Syrup is for use in adults and adolescents over 12 years of age. You must talk to a doctor if you do not feel better or if you feel worse after 7 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUTTERCUP BRONCHOSTOP® COUGH SYRUP Do not take Buttercup Bronchostop® Cough Syrup If you are allergic to Marshmallow root, Thyme or other members of the Lamiaceae family (e.g. Basil, Rosemary, Sage), or to any of the other ingredients of this medicine (listed in section 6). If you are pregnant or breast-feeding. Warnings and precautions 2/5 Talk to your doctor or pharmacist before taking Buttercup Bronchostop® Cough Syrup If yo Read the complete document
Health Products Regulatory Authority 25 January 2023 CRN00D08J Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Buttercup Bronchostop Cough Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 15 ml of syrup (~15.45 g) contains: 0.12 g of dry extract from _Thymus vulgaris_ L. and _Thymus zygis_ L. herba (thyme herb) (7-13:1) Extraction solvent: water and 0.83 g liquid extract from _Althaea officinalis_ L. radix (marshmallow root) (DER 1:12-14) Extraction solvent: water. Excipients with known effect: 15 ml of syrup contains 11.59 mg of methyl parahydroxybenzoate (E218), 6.18 mg of propyl parahydroxybenzoate (E216),approximately 130 mg of total sugars (which includes 66 mg of fructose) from raspberry juice concentrate (containing sucrose, glucose and fructose) and 33.3 mg propylene glycol (E1520) contained in raspberry aroma flavour. 3 PHARMACEUTICAL FORM Syrup Brown-red viscous liquid 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Traditional herbal medicinal product used for the relief of coughs, such as chesty, dry, tickly, irritating coughs and catarrh exclusively based on long standing use. Buttercup Bronchostop Cough Syrup is indicated in adults and children aged 12 years and over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral short-term use only. Adults, the elderly and children over 12 years: Using the measuring cup provided, 15 ml of syrup to be taken every 4 hours, 4 times per day. If required, up to a maximum of 6 doses (90 ml) can be taken per day. _Method of administration:_ Buttercup Bronchostop Cough Syrup may be administered undiluted or diluted in water or warm tea. This product is not recommended for use in children under 12 years of age (See ‘Section 4.4 Special warnings and precautions for use.’) _Duration of use:_ If symptoms persist, worsen or do not improve after 7 days use of Buttercup Bronchostop Cough Syrup, a qualified healthcare professional e.g. a doctor or pharmacist should be consulted. Health Products Regulatory Authority 25 January 2023 CRN00D0 Read the complete document