Boots Dry Cough Relief oral solution

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sucrose; Glycerol

Available from:

The Boots Company Plc

ATC code:

n/a

INN (International Name):

Sucrose; Glycerol

Dosage:

340mg/1ml ; 150microlitre/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03090200; GTIN: 5000167078053

Patient Information leaflet

UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE
ALTERED WITHOUT PRIOR PERMISSION FROM WK360.
TECHNICAL INFORMATION, PRINTER PLEASE NOTE:
WK360 HAVE CREATED THIS ARTWORK TO A GENERIC PRINT
PROCESS SPECIFICATION AND REPRO HAS NOT BEEN APPLIED.
PLEASE CALL YOUR CLIENT CONTACT TO DISCUSS ANY AMENDS
OR IF ANYTHING FALLS BENEATH YOUR PRINT TOLERANCES
BRANDING
07/03/2022
DMc
PRINTING COLOURS
Cutter
Guides
TECHNICAL & NON-PRINTING
SPECIAL FINISHES & FOILS
5481.008
THIS SCALE MEASURES 50MM WHEN ARTWORK IS AT 100%
0
10
20
30
40
50
CATEGORY:
SYNERGIST JOB NO:
BRAND:
RANGE:
PROJECT NO.:
PRODUCT TITLE:
FILE NAME:
PROOF NUMBER:
PROOF DATE:
ARTWORKER:
PACK TYPE:
SUPPLIER CONTACT:
FINISH:
FINISH TYPE:
SUBSTRATE:
SUBSTRATE COLOUR:
SUPPLIER DETAILS:
PRINTER CONTACT:
PRINTER DETAILS:
NUMBER OF COLOURS:
BRAILLE:
Health
Boots Own Brand
Cough Cold
23-36-154
EAN13
NEAA1
5000167078053
Dry Cough Relief Oral Solution
Glycerol , Liquid Sugar
7
Gloss & Matt
Carton
Overall
Carton Board
White
6
Yes
WBA-2075-Boots Dry Cough Relief Oral Solution 150ml -
Carton-150-ml-2336154
PACK MOCK UP
ARTWORK TEXT SIZE
MAIN HEADINGS:
10pt
SUB HEADINGS:
9pt
BODY HEADINGS:
8pt
VERSION
NO.
DATE
ISSUED
REASON FOR CHANGE
1
17/12/2021
BVI Redesign
2
02/02/2022
Update to the excipient
wording
Pl 00014/0550
MHRA Approved 09/03/2020
WBAG411988 B
Internally Approved
150 ml
Boots Dry Cough Relief
Oral Solution 150ml
PRODUCT NAME:
PRODUCT LICENCE NO.:
WORDING REF:
STATUS:
PACK DETAILS:
PACK SIZE:
Amber PET Bottle with a
polypropylene child
resistant cap fitted with
expanded polyethylene liner.
Artwork Only
ITEM CODE:
BARCODE TYPE:
BARCODE NO.:
COMPONENT CODE:
PHARMA CODE NO.:
GLOSS
VARNISH
MATT
VARNISH
BRAILLE
PMS
Cool
Gray 5 C
PMS
2087 C
PMS
7678 C
PMS
282 C
ARTWORK
23-36-154
LOT:
USE BY:
NEAA1
If you need more advice
ask your pharmacist.
HOW TO TAKE THIS MEDICINE
Check the seal is not broken before first
use. If it is, do not take the medicine.
This medicine should be swallowed.
Do not give to children under 1 year.
Do not take more than the amount
recommended above.
If

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Boots Tickly Cough Relief Oral Solution
Boots Dry Cough Relief Oral Solution
2
QUALITATIVE AND QUANTITIVE COMPOSITION
Active ingredient
/5 mL
Glycerine
0.75 mL
Liquid sugar
1.93 mL
(Equivalent to sucrose)
(1.70 g)
Excipients of known effect
Glucose
1.58 mL
Sodium benzoate
10 mg
3
PHARMACEUTICAL FORM
Oral Solution
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of irritating, tickling dry coughs and sore throats.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 5 years: 10 ml.
Children 1 - 5 years: 5 ml.
The dose may be repeated three or four times a day.
Children under one year: Not to be given to children under 1 year.
Elderly: There is no need for dosage reduction in the elderly.
For oral administration.
4.3.
CONTRA-INDICATIONS
Hypersensitivity or intolerance to any of the ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Diabetics should take note of the carbohydrate contents of this
product.
Do not give to children under one year.
Keep all medicines out of the reach of children.
This medicine contains glucose. May be harmful to the teeth. Patients
with
rare glucose-galactose malabsorption should not take this medicine.
This medicine contains 10 mg of sodium benzoate in each 5 ml which is
equivalent to 2 mg /1 ml.
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml, that
is to
say essentially 'sodium-free'.
4.5.
INTERACTIONS WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
No clinically significant interactions known.
4.6.
PREGNANCY AND LACTATION
The safety of this product during pregnancy and lactation has not been
established, but is not considered to constitute a hazard during these
periods.
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable.
4.8
UNDESIRABLE EFFECTS
Immune system disorder: hypersensitivity reactions, including
anaphylaxis.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal
product is imp