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BOOTS SORE THROAT RELIEF DUAL ACTION LOZENGES BLACK CHERRY

Active substance(s): HEXYLRESORCINOL / HEXYLRESORCINOL / HEXYLRESORCINOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Sore Throat Relief Dual Action Lozenges Black Cherry Flavour

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each lozenge contains Hexylresorcinol 2.4mg
For excipients see Section 6.1

3.

PHARMACEUTICAL FORM
Lozenge
A round red lozenge

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
As an antiseptic and local anaesthetic for the relief of sore throat and its associated pain.

4.2.

Posology and Method of Administration
For oral administration.
Adults, the elderly and children 6 years and over: One lozenge dissolved
slowly in the mouth every three hours or as required.
Do not take more than 12 lozenges in 24 hours.
Not to be given to children under 6 years.

4.3.

Contra-indications
Hypersensitivity to any of the ingredients.

4.4.

Special Warnings and Precautions for Use
The label will convey:
Keep out of the reach and sight of children.
If symptoms persist consult your doctor.
Not to be given to children under 6 years.
This product is unsuitable in hereditary fructose intolerance, glucose-galactose
malabsorption syndrome, or sucrose-isomaltase deficiency.

4.5.

Interactions with other Medicaments and other forms of Interaction
None known.

4.6.

Pregnancy and Lactation
There is lack of evidence of safety of the product in human pregnancy and in
animals, but hexylresorcinol has been used widely in lozenges for many years
without apparent ill consequence. However, as with all medicines, caution
should be exercised during pregnancy and lactation.

4.7.

Effects on Ability to Drive and Use Machines
None known.

4.8

Undesirable effects
None known
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at
http://www.mhra.gov.uk/yellowcard

4.9.

Overdose
Hexylresorcinol overdosage may cause minor gastrointestinal irritation.
Treatment would be withdrawal of the product and symptomatic measures as
appropriate.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Hexylresorcinol is a local anaesthetic for topical use on the mucous membranes of the mouth
and throat. Mild antiseptic activity has also been demonstrated.
The product base has a demulcent action.

5.2.

Pharmacokinetic Properties
Pharmacokinetic considerations do not arise since the pharmacological action
is local to the oro-pharyngeal cavity.

5.3.

Preclinical Safety Data
There are no preclinical data of relevance additional to those already included
in other sections of the SPC.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Liquid sucrose,
Liquid glucose,
Propylene glycol,
Cherry flavour
Levomenthol,
Carmoisine edicol (E122)

6.2.

Incompatibilities
Not applicable

6.3.

Shelf-Life
24 months.

6.4.

Special Precautions for Storage
Do not store above 25°C.
Store in the original packaging.
Keep in the outer carton.

6.5

Nature and contents of container
Blister packs of 250 micron PVC/Coated 40gsm PVdC with 20 micron hard
temper aluminium foil, heat sealed to the blister.
Pack sizes: 16, 24, 36 lozenges.

6.6.

Instructions for Use, Handling and Disposal
None specific to the product/pack

7.

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
Thane Road West
Nottingham
NG2 3AA
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 00014/0639

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
20/11/2007

10

DATE OF REVISION OF THE TEXT
15/07/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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