Family Meltus Chesty Coughs Honey & Lemon Flavour

1. Name Of The Medicinal Product

Family Meltus Chesty Coughs Honey and Lemon Flavour

2. Qualitative And Quantitative Composition

Guaifenesin BP 50.00mg/5ml.

3. Pharmaceutical Form

Syrup.

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic relief of deep chesty coughs and to soothe the throat.

4.2 Posology And Method Of Administration

Route of administration: Oral. To be taken three or four times daily.

Adults and children over 12 years: Two to four 5ml spoonfuls.

Children 6–12 years: Two 5ml spoonfuls.

Children 2-6 years: One 5ml spoonful.

Children under 2 years: On medical advice only.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

None.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

May be used.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Some gastrointestinal discomfort has been reported.

4.9 Overdose

Very large doses may cause nausea and vomiting. The drug is, however, rapidly metabolised and excreted in the urine. Treatment: The patient should be kept under observation and treated symptomatically.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Guaifenesin is an expectorant. The sugar, honey and glycerin have a demulcent effect.

5.2 Pharmacokinetic Properties

Guaifenesin is absorbed from the gastrointestinal tract. It is metabolised and excreted in the urine.

5.3 Preclinical Safety Data

There are no preclinical 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

Purified Honey BP; Sunset Yellow E110; Sucrose, Granular BP; Glycerin BP; Tolu Flavour Solution–Sugar Free HSE; Sodium Benzoate BP; Citric Acid Monohydrate BP; Lemon Oil Terpeneless BP; Isopropyl Alcohol BP; Sodium Cyclamate Ph Eur; Purified Water USP.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Store below 20^oC.

6.5 Nature And Contents Of Container

Amber glass sirop bottles fitted with a tamper evident cap with fitted polycone liner packed in an outer carton containing 100ml of product.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Cupal Ltd. Venus, 1 Old Park Lane, Trafford Park, Manchester M41 7HA

8. Marketing Authorisation Number(S)

PL 0338/0064.

9. Date Of First Authorisation/Renewal Of The Authorisation

17^th November 1987 /26^th February 2004.

10. Date Of Revision Of The Text

August 2006