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BOOTS CHILDRENS 3 MONTHS PLUS VAPOUR RUB

Active substance(s): EUCALYPTUS OIL / LEVOMENTHOL / RACEMIC CAMPHOR / EUCALYPTUS OIL / LEVOMENTHOL / RACEMIC CAMPHOR / EUCALYPTUS OIL / LEVOMENTHOL / RACEMIC CAMPHOR

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Children's Vapour Rub

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Racemic Camphor
Levomenthol natural or synthetic
Eucalyptus oil

3.

%w/w
6.0
1.0
1.5

PHARMACEUTICAL FORM
Ointment

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For head colds, stuffy nose, cough and chest colds.

4.2

Posology and method of administration
For children over 2 years and adults
Apply a small amount on the chest and back particularly at bedtime. Rub gently and
leave clothes loose for easy inhalation. Apply a moderate amount on older children
and adults.
Elderly
There is no need for dosage reduction.
Children under 2 years
Not recommended for children under 2 years of age.
For topical application.

4.3

Contraindications
Hypersensitivity to any of the ingredients.
Do not use on children under 2 years of age.

4.4

Special warnings and precautions for use
For external use only.
Do not apply around the nostrils, mouth, eyes or face.
Do not use on broken skin or wounds.
Keep all medicines out of the sight and reach of children

4.5. Interactions with other Medicaments and other forms of
Interaction
No clinically significant drug interactions known.

4.6

Fertility, pregnancy and lactation
The safety of vapour rub during fertility, pregnancy and lactation has not been
established. As a precaution this product should not be used without medical advice
during pregnancy. This product should not be used on the mother’s chest during
breastfeeding.

4.7.

Effects on Ability to Drive and Use Machines
No adverse effects known.

4.8

Undesirable effects
Occasional hypersensitivity and irritant skin reactions.
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
Over dosage may result in skin irritation.

Misuse:
Swallowing of the ointment might cause gastrointestinal symptoms like
vomiting and diarrhoea. Treatment is symptomatic.
Following oral ingestion, symptoms of overdosage may include colic,
dizziness, delirium, muscle twitching, epileptiform convulsions and depression
of the central nervous system. Breathing may be difficult. There may also be
haematuria and albuminuria.
Acute poisoning was observed after significant accidental consumption, with
nausea, vomiting, abdominal pain, and headache, vertigo, feeling hot /
flushing, convulsions, respiratory depression and coma.
Patients with severe gastrointestinal or neurological symptoms of poisoning
should be observed and treated symptomatically. Do not induce vomiting.
Convulsions may be controlled by the intravenous administration of diazepam
5-10 mg.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Eucalyptus oil, camphor, levomenthol are volatile substances and are thought to
produce an irritant effect on the respiratory tract, probably via a nasal/puhnonary arc.

5.2.

Pharmacokinetic Properties
None stated.

5.3.

Preclinical Safety Data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
White soft paraffin

6.2.

Incompatibilities
None stated.

6.3.

Shelf Life
36 months in amber glass jar.
20 months in polystyrene jar.

6.4.

Special Precautions for Storage
Amber glass jar - None.
Polystyrene jar - Do not store above 25°C.

6.5.

Nature and Contents of Container
Amber glass jar with either a tin plate cap with waxed aluminium faced
pulpboard liner containing 45g or a thermoset plastic cap
or A polystyrene jar with an unlined polypropylene cap containing 25g or 45g.

6.6.

Instruction for Use/Handling
None.

7.

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham, NG2 3AA

8

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0562

9.
DATE OF FIRST AUTHORISATION/RENEWAL OF
AUTHORISATION
31 May 1996

10

DATE OF REVISION OF THE TEXT
22/12/2016

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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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