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Mackenzies Smelling Salts
Active Ingredient:
Company:
Dexcel Pharma Ltd
See contact details
ATC code:
R01A X
About Medicine
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This information is for use by healthcare professionals
Last updated on emc: 25 Oct 2024
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1. Name of the medicinal product
MACKENZIES SMELLING SALTS
2. Qualitative and quantitative composition
Contains not less than 8.820g Ammonia Liquor 880/890 and 0.539g Eucalyptus Oil.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
White granules.
4. Clinical particulars
4.1 Therapeutic indications
1) Traditionally used for the symptomatic relief of catarrh and head colds.
4.2 Posology and method of administration
Posology
Inhale vapour through nostrils as required.
Do not use for children under 3 months of age.
Method of Administration
Inhalant.
4.3 Contraindications
Do not use for children under 3 months of age.
4.4 Special warnings and precautions for use
None known.
The product labelling includes the following statements:
Not to be taken.
If symptoms persist consult your doctor.
Keep out of the reach and sight of children.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
No special precautions are considered necessary.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
None known.
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; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
No special requirements are anticipated.
5. Pharmacological properties
5.1 Pharmacodynamic properties
ATC code: R01A X
Ammonia is employed in the product as a reflex stimulant.
Eucalyptus oil is an essential oil.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. Pharmaceutical particulars
6.1 List of excipients
Also contains glycerol, soft soap, tapioca, water.
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf-life
Three years from the date of manufacture.
Shelf-life after dilution/reconstitution
Not applicable.
Shelf-life after first opening
Not applicable.
6.4 Special precautions for storage
Store in a cool place.
6.5 Nature and contents of container
The product container is a uniquely-shaped amber glass bottle with black HDPE cap with LDPE liner.
Pack size: 17ml
6.6 Special precautions for disposal and other handling
Not applicable.
7. Marketing authorisation holder
Dexcel® -Pharma Ltd.
7 Sopwith Way, Drayton Fields,
Daventry, Northamptonshire NN11 8PB
United Kingdom
8. Marketing authorisation number(s)
PL 14017/0313
9. Date of first authorisation/renewal of the authorisation
16.10.86 (Product Licence of Right issued: 27.7.73)
Renewed: 14.5.92; 11.7.97
10. Date of revision of the text
23/04/2024
Dexcel Pharma Ltd
Address
7, Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
Telephone
+44 (0)1327 312 266
Fax
+44 (0)1327 312 262
Medical Information e-mail
[email protected]
Medical Information Direct Line
+44 (0) 1748 828 784
Out of Hours Telephone
+44 (0) 1748 828 784
E-mail
[email protected]
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