1. Name Of The Medicinal Product
Boots Sore Throat Relief Lozenges Orange and Menthol Flavour or Antiseptic Throat Drops Orange and Menthol with Vitamin C
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Lozenge.
4. Clinical Particulars
4.1 Therapeutic Indications
For the short-term symptomatic relief of sore throats.
4.2 Posology And Method Of Administration
Adults and children over 12 years : One throat drop to be sucked when required, up to a maximum of 8 throat drops in 24 hours.
Children 5-12 years: One throat drop to be sucked when required to a maximum of 4 throat drops in 24 hours.
Children under 5 years : Not suitable.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special Warnings And Precautions For Use
Keep all medicines out of the reach of children.
Do not exceed the stated dose.
If symptoms persist or worsen see your doctor.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No clinically significant interactions are known.
4.6 Pregnancy And Lactation
The safety of this product has not been established in pregnancy and lactation, but is not expected to constitute a hazard. As with all drugs try to avoid taking them during pregnancy or lactation.
4.7 Effects On Ability To Drive And Use Machines
No adverse effects are known.
4.8 Undesirable Effects
Occasional hypersensitivity reactions and soreness of the tongue are a possibility.
4.9 Overdose
Slight overdosage should not present a problem other than gastrointestinal discomfort. Treatment should be symptomatic. In cases of severe overdosage, empty the stomach by gastric lavage. Administer a saline laxative and activated charcoal by mouth.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Amylmetacresol has antiseptic properties.
5.2 Pharmacokinetic Properties
No data available.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Levomenthol (natural or synthetic)
Solids from Liquid Sugar for confectionery
Solids from Liquid Glucose
Malic Acid
Sweet Orange Oil Special IFF
Annatto WSA acid stab colour
Ascorbic Acid RD-26216
Sodium Ascorbate
6.2 Incompatibilities
None stated.
6.3 Shelf Life
PVC/PVdC blister: 24 months
Laminate wrapper/cellophane bag/carton: 36 months
6.4 Special Precautions For Storage
PVC/PVdC blister: Do not store above 25°C. Store in the original package.
Laminate wrapper/Cellophane bag/Carton: None
6.5 Nature And Contents Of Container
a) PVC/PVdC blisters heat sealed to hard tempered 20 micron aluminium foil.
Pack sizes: 16, 24 lozenges
or
b) Individually wrapped in laminate; 20 lozenges sealed into a cellophane bag and packed into a 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(S)
PL 00014/0458
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 30 March 1995
Date of last renewal: 26 April 2001
10. Date Of Revision Of The Text
July 2008
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