Buttercup Bronchostop Cough syrup

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Thyme; Marshmallow root

Dostopno od:

Omega Pharma Ltd

INN (mednarodno ime):

Thyme; Marshmallow root

Odmerek:

8mg/1ml ; 55.33mg/1ml

Farmacevtska oblika:

Oral suspension

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 03090200; GTIN: 5012616262197 5012616262203 5012616262210

Navodilo za uporabo

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5. HOW TO STORE BUTTERCUP BRONCHOSTOP COUGH SYRUP
Do not store above 25°C.
Store in the original package in order to protect the contents from
light.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not use this medicine after the expiry date which is stated on the
carton.
The expiry date refers to the last day of that month.
Close tightly after use. After opening, use within 4 weeks.
Do not throw away medicines via wastewater or household waste. Ask
your pharmacist how to
throw away medicines you no longer use. These measures help protect
the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT BUTTERCUP BRONCHOSTOP COUGH SYRUP CONTAINS
15 ml of oral syrup (15.45 g) contains the actives substances:
120 mg of extract (as dry extract) from Thyme herb (_Thymus vulgaris_
L. and _Thymus zygis_ L.,herb )
(DER 7-13:1) extraction solvent: water
830 mg of extract (as liquid extract) from Marshmallow root (_Althaea
officinalis_ L.) (DER 1:12-14)
extraction solvent: water
THE OTHER INGREDIENTS ARE:
Maltodextrin, Acacia (E414), Xylitol (E967), Methyl
parahydroxybenzoate (E218), Raspberry juice
concentrate (containing sucrose, glucose and fructose), Xanthan gum,
Citric acid monohydrate,
Propyl parahydroxybenzoate (E216), Raspberry aroma flavouring
(synthetic and natural
flavourings, propylene glycol (E1520)), glycerol (E422),
saccharin-sodium (E954), neohesperidin-
dihydrochalcone, Purified water
WHAT BUTTERCUP BRONCHOSTOP COUGH SYRUP LOOKS LIKE AND CONTENTS OF THE
PACKAGE
Buttercup Bronchostop Cough Syrup is a brown-red, viscous liquid. The
syrup is contained in
brown glass bottles with a sealed screw cap, in 120 ml, 200 ml and 240
ml sizes. Not all pack sizes
may be marketed.
The package includes a measuring cup with a scale from 2.5 ml to 20 ml
which allows precise
measuring of the recommended dose.
THR HOLDER
Omega Pharma Ltd, Wrafton, Braunton, Devon, EX33 2DL, UK
MANUFACTURER
Kwizda Pharma GmbH, Effinge

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Buttercup Bronchostop Cough Syrup
2.
QUALITATIVE AND QUANTATIVE COMPOSITION
15 ml of syrup (15.45 g) contains:
120 mg of extract (as dry extract) from Thyme herb (_Thymus vulgaris
_L._ _and _Thymus _
_zygis _L., herb) (DER 7-13:1) extraction solvent: water
and
830 mg of extract (as liquid extract) from Marshmallow root (_Althaea
officinalis _L.)
(DER 1:12-14) extraction solvent: water
Excipient(s) with known effect:
Each single dose (15 ml) contains
11.59
mg
of
methyl
parahydroxybenzoate
(E218),
6.18
mg
of
propyl
parahydroxybenzoate
(E216)
and
131
mg
total
sugars
from
raspberry
juice
concentrate (containing sucrose, glucose and fructose) and 38.9 mg
propylene glycol
(E1520) contained in raspberry aroma flavour (See ‘Section 4.4
Special warnings and
precautions for use’)
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oral 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 coughs and dry, tickly, irritating coughs and catarrh based on
traditional
use only.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral 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 (90ml) 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 worsen, or persist after 7 days, a doctor or a qualified
healthcare
practitioner should be consulted.
4.3
CONTRAINDICATIONS
Hypersensitivity to marshmallow root, thyme, to other members of the
Lamiaceae
family or to any of the excipients listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTION