Strepsils Sore Throat & Blocked Nose Lozenges Amylmetacresol 0.6mg 2,4-Dichlorobenzyl Alcohol 1.2mg Levomenthol 8.0mg

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

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Tờ rơi thông tin Tờ rơi thông tin (PIL)
03-05-2019

Thành phần hoạt chất:

Amylmetacresol; Levomenthol; 2,4-Dichlorobenzyl alcohol

Sẵn có từ:

Reckitt Benckiser Ireland Ltd

Mã ATC:

R02AA; R02AA03

INN (Tên quốc tế):

Amylmetacresol; Levomenthol; 2,4-Dichlorobenzyl alcohol

Liều dùng:

0.6 mg/1.2 mg/8 milligram(s)

Dạng dược phẩm:

Lozenge

Loại thuốc theo toa:

Product not subject to medical prescription

Khu trị liệu:

Antiseptics; dichlorobenzyl alcohol

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

1991-01-30

Tờ rơi thông tin

                                CUSTOMER INFO:
Minimum Point Size =
7.00pt
5.3 mm
85%
EAN 13
5000158100879
14.2 mm
0 microns
N/A
17.0 mm
BARCODE INFO
Barcode Type:
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ZEN Ref:
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(2D if applicable)
:
Parent Technical Packaging
Specification:
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3rd Party Code
Pharmacode No/NE:
Edgemark Position:
CAD Cam Ref:
Printer:
Substrate:
100110110(821)
NA
RB Nottingham
6,B,u
0271103
Strepsils
Throatcare
Sore Throat & Blocked Nose
16/36
12Pack
RB364464
Please note that any low resolution paper Canon colour copies
associated with this job should be referred to for content, layout
and colour separation only.
STUDIO USE ONLY
v2.0
Sm•Art check results:
Cutter
Guides
Technical & Non Printing Items
Cutter 2 (if applicable)
Guides 2 (if applicable)
Multi Packaging Solutions (Nottingham, UK)
S-Crt-FB-S1-Flipped-79x109x21mm-D0069669-(Lottie)
TR1551622
Carton Board - White
Ireland
27/02/19
B
Siobhan Eyre
3096656
G=2; O=2; R=0; - SE - 27/02/19 10:48:55
RB Artwork and
Print Specification
D0069669
Artwork Type:
IDM Commercial
10
mm
20
30
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50
60
70
80
90
100
110
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1
LTH
Process Black
2
LTH
Varnish-Water Based Emulsion
3
LTH
Braille
4
LTH
PANTONE 321 C
5
LTH
Process Yellow
Colours (Carton)
RBH Contact:
Jillian Buckle
Connaught House, Connaught Road,
Kingswood Business Park, Hull, HU7 3AP, England.
T: +44 (0) 1482 828100
UNDER NO CIRCUMSTANCES SHOULD THIS
ARTWORK BE ALTERED WITHOUT PRIOR
PERMISSION FROM TRIDENT.
S t r e p s i l s S o r e
Throat &
B l o c k e d N o s e
T B R 7 5 1 - S 1 - M M 2 – E n g l i s h A l p h a b e t
_DUAL_ anti-bacterial action
LOT:
DO NOT USE AFTER:
24 lozenges
LOZENGES
AMYLMETACRESOL 0.6MG
2,4-DICHLOROBENZYL ALCOHOL 1.2MG
LEVOMENTHOL 8MG
Soothing effective relief for sore throats
LOZENGES
LOZENGES
LOZENGES
® SORE THROAT AND BLOCKED NOSE L
                                
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Đặc tính sản phẩm

                                Health Products Regulatory Authority
16 July 2021
CRN00C5NY
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Sore Throat & Blocked Nose Lozenges Amylmetacresol 0.6mg
2,4-Dichlorobenzyl Alcohol 1.2mg Levomenthol 8.0mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
Amylmetacresol
0.6
mg
2, 4-Dichlorobenzyl alcohol
1.2
mg
Levomenthol
8.0
mg
Excipients with known effects:
Glucose 1.013 g (1013 mg)/lozenge.
Sucrose 1.496 g (1496 mg)/lozenge.
Wheat Starch (containing gluten, present in liquid glucose) 20.26
micrograms/lozenge.
Eucalyptus oil fragrance containing d-Limonene.
Sulphites - Sulphur Dioxide (E220), present in liquid glucose 0.130
ppm/lozenge.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Lozenge.
A blue, circular lozenge with a characteristic taste, embossed on both
sides with strepsils brand icon.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of mouth and throat infections and nasal
congestion.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms. It is recommended that the
product should be used for a maximum of 3 days.
ADULTS;
One lozenge every 2-3 hours. Do not take more than 12 lozenges in 24
hours.
PAEDIATRIC POPULATION:
Children over 6 years of age:
As above for adults.
Children under 6 years of age:
Not suitable for children under 6 years (see section 4.4)
ELDERLY:
There is no need for dosage reduction in the elderly.
METHOD OF ADMINISTRATION:
For oromucosal administration, To be dissolved slowly in the mouth.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
16 July 2021
CRN00C5NY
Page 2 of 4
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product is not recommended for young children due to a risk of
choking.
Consult your doctor if symptoms persist or if anything unusual
happens.
This medicine
                                
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