Buttercup Bronchostop Day & Night Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Available from:

Chefaro Ireland DAC

ATC code:

R05X

Dosage:

.

Pharmaceutical form:

Oral solution

Therapeutic area:

OTHER COLD PREPARATIONS

Authorization status:

Marketed

Authorization date:

2021-02-26

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BUTTERCUP BRONCHOSTOP DAY & NIGHT ORAL SOLUTION
Marshmallow root dry extract
Lime flower dry extract
Ribwort plantain dry extract
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
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 doctor or 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 Day & Night oral solution
is and what it is used for
2.
What you need to know before you take Buttercup Bronchostop Day &
Night oral
solution
3.
How to take Buttercup Bronchostop Day & Night oral solution
4.
Possible side effects
5.
How to store Buttercup Bronchostop Day & Night oral solution
6.
Contents of the pack and other information
1.
WHAT BUTTERCUP BRONCHOSTOP DAY & NIGHT ORAL SOLUTION IS AND WHAT IT IS
USED FOR
Buttercup Bronchostop Day & Night oral solution contains the active
substances
marshmallow root, lime flower and ribwort plantain extracts.
Traditional herbal medicinal product used for symptomatic relief of
sore throat, dry cough and
flu-like symptoms associated with common cold.
The product is a traditional herbal medicinal product for use in the
specified indications
exclusively based upon long-standing use in adults and adolescents
aged 12 years and over.
If the symptoms worsen, persist or do not improve after 7 days, a
qualified healthcare
professional e.g. a doctor or pharmacist should be consulted.
HOW BUTTERCUP BRONCHOSTOP DAY & NIGHT ORAL SOLUTION WORKS
Based on empirical observations from traditional use, the thick, gluey
substances contained in
marshmallow root, lime flower and ribwort plan

Summary of Product characteristics

Health Products Regulatory Authority
21 May 2021
CRN00CC2H
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Buttercup Bronchostop Day & Night Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 15 ml (= 16.3 g) of oral solution contains:
187.5 mg of extract (as dry extract) from_ Althaea officinalis _L._,
_radix (Marshmallow root) (7-9:1). Extraction solvent: water
136.4 mg of extract (as dry extract) from _Tilia cordata_ Miller,
_Tilia platyphyllos_ Scop., _Tilia_ x _vulgaris_ Heyne or their
mixtures, flos
(Lime flower) (3-8:1). Extraction solvent: water
150.0 mg of extract (as dry extract) from _Plantago lanceolata_ L.,
folium (Ribwort plantain leaf) (4-6:1). Extraction solvent: water
Excipients with known effect:
Each 15 ml of oral solution contains 2.76 g xylitol (E967), 11.3 mg
methyl-parahydroxybenzoate (E 218), 6.6 mg propyl
parahydroxybenzoate (E216) and strawberry flavour (containing 13.6 mg
propylene-glycol and 0.0018 mg benzyl-alcohol)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Brown opaque liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Traditional herbal medicinal product used for symptomatic relief of
sore throat, dry cough and flu-like symptoms associated
with common cold.
Buttercup Bronchostop Day & Night oral solution is indicated for use
in adults and adolescents aged 12 years and over.
The product is a traditional herbal medicinal product for use in the
specified indication exclusively based upon long-standing
use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Start at the first sign of the common cold (sore throat, dry cough and
flu-like symptoms).
Posology
_Adults and adolescents aged 12 years and above: _
Using the measuring cup provided, 15 ml of oral solution should be
taken as required up to four times daily (the maximum
recommended dose is 60 ml in 24 hours). The last dose should be taken
directly before bedtime.
_Paediatric population_
Children under 12 years:
The use in children under 12 years of