Strepsils Orange with Vitamin C Lozenges Amylmetacresol 0.6mg 2,4-Dichlorobenzyl Alcohol 1.2mg Vitamin C 100mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amylmetacresol; 2, 4-dichlorobenzyl alcohol; Vitamin c

Available from:

Reckitt Benckiser Ireland Ltd

ATC code:

R02AA; R02AA03

INN (International Name):

Amylmetacresol; 2, 4-dichlorobenzyl alcohol; Vitamin c

Dosage:

0.6 mg/1.2 mg/100 milligram(s)

Pharmaceutical form:

Lozenge

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antiseptics; dichlorobenzyl alcohol

Authorization status:

Marketed

Authorization date:

1985-09-24

Patient Information leaflet

4.9 mm
85%
EAN 13
5000167070194
14.6 mm
0 microns
N/A
17.4 mm
BARCODE INFO
Barcode Type:
Barcode Number:
Magnification:
Truncated By:
Full Height:
Bar Height (Smallest Bar):
BWR:
Encoded Data:
Trident Reference No:
ZEN Ref:
Action:
Brand:
Category:
Segment Group:
Segment:
Pack Size:
Market/Country:
Date:
Component Code
(2D if applicable)
:
Parent Technical Packaging
Specification:
Finished Goods Code:
Supply Point:
3rd Party Code
Pharmacode No/NE:
Edgemark Position:
CAD Cam Ref:
Printer:
Substrate:
1111111011(2042)
NA
RB Nottingham
1, X, Y, Z
0271100
Strepsils
Throatcare
Orange Vitamin C
24
24Pack
RB364530
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-D0278923-(Lottie)
TR1551733
Carton Board - White
Ireland
12/03/19
C
Siobhan Eyre
3096658
G=2; O=2; R=0; - SE - 12/03/19 08:19:26
RB Artwork and
Print Specification
D0278923
Artwork Type:
IDM Commercial
10
mm
20
30
40
50
60
70
80
90
100
110
120
130
140
150
160
170
180
190
200
210
220
230
240
250
1
LTH
Varnish-Water Based Emulsion
2
LTH
Process Black
3
LTH
PANTONE 1665 C
4
LTH
Process Yellow
5
LTH
Process Cyan
6
LTH
Braille
7
LTH
Emboss
Colours (Carton)
RBH Contact:
Jillian Buckle
Connaught House, Connaught Road,
Kingswood Business Park, Hull, HU7 3AP, England.
T: [phone]
UNDER NO CIRCUMSTANCES SHOULD THIS
ARTWORK BE ALTERED WITHOUT PRIOR
PERMISSION FROM TRIDENT.
(Refers to the “with” within
Orange with Vitamin C Lozenges
on the SOPs, everything else is a
minimum of 7pt.
BOP copy is min 8.5pt).
CUSTOMER INFO:
Minimum Point Size =
S t r e p s i l s
O ra n g e w i t h
Vi t a m i n C
T B R 7 4 7 - D 0 2 7 8 9 2 3 – E n g l i s h A l p h a b e t
6.49pt
LOT:
DO NOT USE AFTER:
24
lozenges
Soothing effective relief for sore throats
_DUA

Summary of Product characteristics

Health Products Regulatory Authority
16 July 2021
CRN00C5NY
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Strepsils Orange with Vitamin C Lozenges Amylmetacresol 0.6mg
2,4-Dichlorobenzyl Alcohol 1.2mg Vitamin C 100mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains 0.6 mg Amylmetacresol, 1.2 mg 2,
4-Dichlorobenzyl Alcohol and 100 mg Vitamin C (as Ascorbic Acid
and Sodium Ascorbate).
Excipients with known effects:
Glucose 0.97 g (968 mg)/lozenge.
Sucrose 1.44 g (1438 mg)/lozenge.
Propylene glycol 3 mg/lozenge.
Wheat Starch (containing gluten present in liquid glucose) 19.36
micrograms/lozenge.
Sulphites - Sulphur Dioxide (E220) present in liquid glucose 0.124
ppm/lozenge.
Orange flavour fragrances containing citral, citronellol, d-Limonene,
geraniol and linalool.
Colouring agents Ponceau 4R (E124) and Sunset yellow (E110).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lozenge
An orange flavoured and coloured circular lozenge. Embossed on both
sides with strepsils brand icon.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of mouth and throat infection.
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 populations
Children over 6 years of age:
As above for adults.
Children under 6 years of age:
Notsuitable 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.
Health Products Regulatory Authority
16 July 2021
CRN00C5NY
Page 2 of 6
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Patients with rare hereditary problems of fructose intolerance