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Thornton & Ross Bronchial Balsam Syrup

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Regulatory Approved text for Non-Marketed packs for Thornton & Ross Bronchial

Balsam Syrup


Front Label

Thornton & Ross Bronchial Balsam Syrup

Dextromethorphan Hydrobromide Levomenthol

Effective relief of troublesome dry coughs and irritation in the throat and chest Troublesome Dry Coughs Rapid Impact

Back Label/Leaflet

Top Ply Face

IMPORTANT: Peel top leaf and read all text inside BEFORE use.

Do not peel off, re-fix for future use.

Peel Here

Thornton & Ross Bronchial Balsam Syrup is for relief of the symptoms of dry coughs from colds and bronchitis.

SHAKE THE BOTTLE VIGOROUSLY.

Take the solution by mouth.

Adults, the elderly and children over 12 years:

Take 2 x 5ml spoonfuls every 4 hours if required.

Do not give to children under 12 years old unless your doctor tells you to. DO NOT EXCEED THE STATED DOSE.

Talk to your doctor before use if you have a history of asthma.

Peel where shown for further precautions

If symptoms persist consult your doctor.

Do not store above 25°C.

Keep out of the reach and sight of children.

Active ingredients per 5ml: dextromethorphan hydrobromide 7.5mg, menthol 2.5mg.

Also contains: ethanol, glycerol (E422), sucrose,

Alcohol 0.18 vol%, Sucrose 3.07g per 5ml. See reverse for full list.

MA holder and manufacturer

Thornton and Ross Ltd.

Huddersfield.

HD7 5QH, UK.

PL00240/0365

Barcode

Overprint Area (BN, Expiry)

P

150mle Carrier Face

Thornton & Ross Bronchial Balsam Syrup contains dextromethorphan which reduces the desire to cough and menthol which relieves irritation, reduces congestion and helps you breathe more easily.

1. Before you use this medicine Do not use the medicine if you have...

•An allergy to any of the ingredients listed in section 3 Taken MAOIs (monoamine oxidase inhibitors) for depression within the last two weeks Shortage of breath-Liver problems •An asthma attack -A persistent cough or one which produces phlegm • Or are under 12 years.

Talk to your doctor if you have.

•A history of asthma

■Talk to your doctor or pharmacist if you are taking..

•Cimetidine for stomach ulcers.

■Pregnant or breastfeeding..

Ask your doctor of pharmacist for advice before using if you are pregnant, might be pregnant or are breastfeeding. ■Driving and using machines..

This medicine normally works without causing drowsiness, but care should be taken initially as in rare cases drowsiness may occur. If you are affected do not drive or operate machinery.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking this medicine until you know

how it affects you.

•    It is an offence to drive if this medicine affects your ability to drive

•    However, you would not be committing an offence if:

° The medicine has been prescribed to treat a medical

or dental problem and

° You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

° It was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Important Ingredient Information

•Contains 3.07g of sucrose per 5ml dose. This should be taken into account in people with diabetes. If you have an intolerance to some sugars, contact your doctor before taking this medicine.

•It contains small amounts of ethanol (alcohol), less than 100mg per 10ml dose.

Top Ply Reverse Face

2.    Possible Side Effects

Like all medicines, Thornton & Ross Bronchial Balsam Syrup can have side effects, although these don’t affect everyone.

Possible side effects: drowsiness •dizziness •sickness or feeling sick •constipation •stomach discomfort If you notice these or other side effects not listed, stop use and tell your doctor or pharmacist.

3.    FURTHER INFORMATION

If you accidentally take too much see a doctor straight away. Take the pack with you to show which medicine you have swallowed.

•Do not use after the expiry date. The expiry date refers to the last day of that month.

•Return any unused medicine to the pharmacy for disposal

The active ingredients per 5ml are: dextromethorphan hydrobromide 7.5mg, menthol 2.5mg.

The other ingredients are: ethanol, glycerol (E422), capsicum tincture (capsicum oleoresin), peppermint oil, anise oil, citric acid (E330), macrogol cetostearyl ether, caramel (E150), diethyl ether, cineole, chloroform, sucrose and purified water.

What the medicine looks like

Thornton & Ross Bronchial Balsam Syrup is a brown syrupy liquid.

It is supplied in 150ml bottles.

This label was revised in April 2014