Summary of Product Characteristics Updated 11-Feb-2021 | Teva UK Limited
MACKENZIES SMELLING SALTS
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.
White granules.
1) Traditionally used for the symptomatic relief of catarrh and head colds.
Posology
Inhale vapour through nostrils as required.
Do not use for children under 3 months of age.
Method of Administration
Inhalant.
Do not use for children under 3 months of age.
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.
None known.
No special precautions are considered necessary.
None known.
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.
No special requirements are anticipated.
ATC code:R01A X
Ammonia is employed in the product as a reflex stimulant.
Eucalyptus oil is an essential oil.
Not applicable.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Also contains glycerol, soft soap, tapioca, water.
None known.
Shelf-life
Three years from the date of manufacture.
Shelf-life after dilution/reconstitution
Not applicable.
Shelf-life after first opening
Not applicable.
Store in a cool place.
The product container is a uniquely-shaped amber glass bottle with black HDPE cap with LDPE liner.
Pack size: 17ml
Not applicable.
Administrative Data
Teva UK Limited
Ridings Point,
Whistler Drive,
Castleford,
WF10 5HX,
United Kingdom
PL 00289/2207
16.10.86 (Product Licence of Right issued: 27.7.73)
Renewed: 14.5.92; 11.7.97
29/01/2021
Field House, Station Approach, Harlow, Essex, CM20 2FB
+44 (0)207 540 7000
0800 590 502
www.tevauk.com
+44 (0)207 540 7117
+44 (0) 207 000 1216