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BELLS HEALTHCARE COUGH LINCTUS ORAL SOLUTION

Active substance(s): AMMONIUM CHLORIDE / LEVOMENTHOL / SODIUM CITRATE / SQUILL TINCTURE

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1. NAME OF THE MEDICINAL PRODUCT
Menthodex Cough Mixture
Bell’s Healthcare Cough Linctus Oral Solution
Gordons Cough & Cold Linctus
Morrisons Cough Linctus Oral Solution

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Name of the active substance(s); each 5ml contains
Ammonium Chloride
Sodium Citrate
Levomenthol
Squill Tincture

100.0 mg
50.0 mg
7.75 mg
0.001 ml

Excipient(s) with known effect: methyl hydroxybenzoate E218
Each 10 ml dose contains 3.2 g sucrose and less than 100mg ethanol
For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Oral Solution

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
For the symptomatic relief of colds, sore throats, irritating and chesty coughs.

4.2.

Posology and method of administration
Oral administration
Adults: two 5 ml spoonfuls
Children (7-14 years): One 5 ml spoonfuls
Dose may be repeated three times a day and at bedtimes

4.3.

Contra-indications

Care should be taken when given to patients with impaired renal function or
hypersensitivity to any of the active ingredients.

4.4

Special warnings and precautions for use
Shake bottle.
If symptoms persist consult your doctor.
This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per
10ml dose.
Contains sucrose and glucose. This should be taken into account inpatients with diabetes
mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactose
malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Contains 10.0 mg methyl hydroxybenzoate E218 per 10 ml dose; may cause allergic reactions
(possibly delayed).

4.5

Interaction with other medicinal products and other forms of interaction
No interactions studies have been performed.
Contains alcohol and should be avoided in patients taking other medicines known to interact
with alcohol (e.g. metronidazole)

4.6.

Pregnancy and lactation
No evidence that this medicine adversely affects pregnancy, however, as with all
medicines it is recommended that Menthodex is not taken during pregnancy.

4.7

Effects on ability to drive and use machines
No studies on the effects on the ability to drive or operate machines have been performed.
Contains alcohol. See Section 2.

4.8

Undesirable effects
Nausea and vomiting have been reported on taking large doses of some ingredients.
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: www.mhra.gov.uk/yellowcard.

4.9

Overdose
It is possible that excessive overdosing may produce nausea and vomiting.
If this occurs, no further action should be necessary except to withdraw medication.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: other cold preparations

ATC code: R05X

Ammonium Chloride acts as an expectorant.
Sodium citrate possesses demulcent properties and helps to relieve irritable coughs.
Squill possess some expectorant properties.
Levomenthol acts as flavouring and helps to relieve symptoms of catarrh.

5.2.

Pharmacokinetic properties
Ammonium chloride is absorbed from the gastro-intestinal tract and is finally
excreted in the urine.
Sodium citrate is absorbed in the gastro-intestinal tract and is finally excreted in the
urine.

5.3.

Preclinical safety data
There is no preclinical data available specific to the product.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Eucalyptus Oil
Star Anise Oil
Ethanol
Sucrose
Glucose
Caramel E150c
Methyl Hydroxybenzoate E218
Liquid Extract of Horehound
Tolu Tincture
Water, purified

6.2.

Incompatibilities
None known

6.3.

Shelf life
36 months in unopened bottle.

6.4.

Special precautions for storage
Do not store above 25°C

6.5.

Nature and contents of container
White or amber glass bottles with ROPP closure and steran wads.
60 ml, 100 ml, 150 ml, 200 ml.

6.6.

Instructions for use/handling
Shake before use.

7.

MARKETING AUTHORISATION HOLDER
Bell, Sons and Co.
Gifford House

Slaidbum Crescent
Southport
Merseyside
PR9 9AL

8.

MARKETING AUTHORISATION NUMBER(S)
PL 03105/0045

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of grant 19 September 1986
Date of renewal 19 November 1993

10

DATE OF REVISION OF THE TEXT
06/04/2016

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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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