Boots Sore Mouth Pastilles: Clinical Particulars
Active ingredient: 2,4-dichlorobenzyl alcohol
- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Antiseptic Sore Mouth Pastilles or Boots Sore Mouth Pastilles
2. Qualitative and quantitative composition
| Active ingredient | mg |
| 2.4 - Dichlorobenzyl alcohol | 1.29 |
3. Pharmaceutical form
Deep orange-coloured, pleasantly flavoured, concave-convex, well glazed pastille with corrugations on the upper convex surface.
4. Clinical particulars
4.1 Therapeutic indications
For the symptomatic relief of sore mouths.
4.2 Posology and method of administration
Adults and children over 3 years: Allow a pastille to dissolve slowly in the mouth every two or three hours during the day, keeping the pastille near the painful area.
Elderly : There is no need for dosage reduction in the elderly.
For oral administration.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Not recommended for children under 3 years.
Keep all medicines out of the reach of children.
4.5 Interaction with other medicinal products 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
No adverse effects known.
4.8 Undesirable effects
Occasional hypersensitivity reactions and soreness of the tongue
4.9 Overdose
No specific symptoms associated with overdosage, other than nausea, vomiting, diarrhoea and soreness of the tongue. Treatment, if required, should be symptomatic.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Dichlorobenzyl alcohol has antiseptic properties.
5.2 Pharmacokinetic properties
No data available.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical particulars
6.1 List of excipients
Silicone antifoam 1510
Glycerin
Annatto WSA acid stab liquid biocon
Purity gum 40 Nat Starch and chemical
Maltitol liquid
Potable water
Adipic acid
Myrrh tincture
Levomenthol natural
Clove leaf oil
Sweet orange oil special IFF
Capol 3073B
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
18 months.
6.4 Special precautions for storage
Store in a dry place below 25°C.
6.5 Nature and contents of container
Clear cellulose film coated with nitrocellulose and heat-sealed to form a bag. Each bag is packed in a cardboard carton.
6.6 Special precautions for disposal and other handling
None.
7. Marketing authorisation holder
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
8. Marketing authorisation number
PL00014/5370R
9. Date of first authorisation/renewal of the authorisation
2 April 1973
10. Date of revision of the text
August 2012