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MAX REMEDIES MOUTH ULCER TABLETS

Active substance(s): AMYLMETACRESOL / ASCORBIC ACID / CETYLPYRIDINIUM CHLORIDE

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Max Remedies Mouth Ulcer Tablets

2

3

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ingredient

mg/tablet

Amyl Metacresol HSE
Ascorbic Acid BP
Cetyl Pyridinium Chloride BP

0.5
25.0
1.5

PHARMACEUTICAL FORM
Compressed lozenge

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Relief of mouth ulcers, gumboils, sore throats and other mouth and throat
infections.

4.2

Posology and method of administration
Method of administration:
Oral.
Adults and children (over 5 years):
Allow one tablet to dissolve slowly in the mouth every two or three hours (not
to exceed 6 in every 24 hours).

4.3

Contraindications
None known.

4.4

Special warnings and precautions for use
Dose not to exceed 6 tablets every 24 hours.
Keep out of the reach of children.

4.5

Interaction with other medicinal products and other forms of interaction
None known.

4.6

Pregnancy and lactation
None known.
No known adverse effect but as with other medicines is best avoided during
the first trimester of pregnancy.

4.7

Effects on ability to drive and use machines
Not applicable.

4.8

Undesirable effects
None known.

4.9

Overdose
Generally well tolerated. Large doses may cause diarrhoea and other gastrointestinal disturbances.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Antiseptic and soothing.

5.2

Pharmacokinetic properties
Not applicable.

5.3

Preclinical safety data
Not known.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Icing Sugar HSE
Acacia BP
Erythrosine (E127) BP
Sodium Saccharin BP
Magnesium Stearate BP
Menthol BP
Phenol BP
Thymol BP
Lemon Oil BP
Spearmint Oil BP
Clove Oil BP
Cinnamon Oil HP
Rose Flavour FF 2544 HSE

6.2

Incompatibilities
None known.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
None.

6.5

Nature and contents of container
20 tablets in a Polypropylene tube and cap.

6.6

Special precautions for disposal
None.

7

MARKETING AUTHORISATION HOLDER
Max Remedies Limited
Stoney Gate House
2 Greenfield Road
Holmfirth
West Yorkshire
HD9 2JT

8

MARKETING AUTHORISATION NUMBER(S)
PL 31308/0025

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
7th March 1979/ 10th July 1994/ 10th July 1999

10

DATE OF REVISION OF THE TEXT
20th July 2009

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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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