- 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
- Administrative data
- 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
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
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
PosologyInhale vapour through nostrils as required.Do not use for children under 3 months of age.
Method of AdministrationInhalant.
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
4.6 Pregnancy and lactation
No special precautions are considered necessary.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
None known.Reporting of suspected adverse reactionsReporting 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
No special requirements are anticipated.
5. Pharmacological properties
5.1 Pharmacodynamic properties
ATC code:R01A XAmmonia is employed in the product as a reflex stimulant.Eucalyptus oil is an essential oil.
5.2 Pharmacokinetic properties
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.
6.3 Shelf life
Shelf-lifeThree years from the date of manufacture.
Shelf-life after dilution/reconstitutionNot applicable.
Shelf-life after first openingNot 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 polypropylene cap with foil wad or black urea formaldehyde cap with polycone.Pack size: 17ml
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
Name or style and permanent address of registered place of business of the holder of the Marketing Authorisation:Actavis UK Limited (Trading style: Actavis)Whiddon ValleyBARNSTAPLEN Devon EX32 8NS
8. Marketing authorisation number(s)
PL 0142/5010 R
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
Actavis UK Ltd
Whiddon Valley, Barnstaple, Devon, EX32 8NS, UK
+44 (0)1271 346 106
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+44 (0)1271 311 200
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+44 (0)1271 385 257