Mackenzies Smelling Salts

1. Name Of The Medicinal Product

MACKENZIES SMELLING SALTS

2. Qualitative And Quantitative Composition

Contains not less than 8.698g Ammonia Liquor 880/890 and 0.5g Eucalyptus Oil BP

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.

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 polypropylene cap with foil wad or black urea formaldehyde cap with polycone.

Pack size: 17ml

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

Administrative Data

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 Valley

BARNSTAPLE

N 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

March 2007