Children’s over-the-counter (OTC) cough and cold medicines

Over the Counter (OTC) cough and cold medicines for children are under review in the UK. The preliminary advice of the Commission on Human Medicines (CHM) was announced in March 2008.

CHM concluded that based upon available evidence the balance of risk and benefits of cough and cold products was no longer favourable in children under 2 years; and therefore should not be used to treat children under 2 years.

The MHRA is gathering and reviewing all available safety and efficacy data; and remains in close liaison with key stakeholders.

The advice from the preliminary announcement in March 2008 still stands. Please see below.

The CHM advised that the product information should be updated for children aged 2-6 years. A wider review involving other medicines for use in both adults and children for nasal symptoms and congestion is on-going. Manufacturers are currently updating the packaging and leaflets for cough and cold products authorised for use in children aged 2- 6 years to include information on the maximum daily dose, a warning not to take with other cough and cold medicines and an instruction to seek advice of a pharmacist or other healthcare professional before using the medicine. Cough and cold medicines should be administered carefully in accordance with the manufacturer's instructions to ensure the child does not receive more than the maximum dose. The safety of all medicines is continually reviewed by the MHRA and action taken as necessary to minimise risk if new safety hazards are identified.

The advice for parents/carers is, if a child has a cough or cold, to use either paracetamol or ibuprofen to relieve pain, and help the child feel better. Use a simple cough mixture containing glycerol, honey and lemon.
For young children, particularly those who are having difficulty feeding, nasal saline drops can be used to help thin and clear nasal secretions.

The MHRA is keeping a close watch on developments in the USA concerning the use of children’s cough and cold remedies and will be considering any implications there are for the UK.

Advice for parents/carers

What should I do with the products I have in my cupboard?
You should review these to see whether there are any which you no longer need or are no longer suitable for under 2s: these can be taken to any pharmacy for safe disposal. For older children, cough and cold medicines may still be useful in reducing symptoms.

What should I do if I have just given one of these products to my child? Do I need to worry if I have just given one of these medicines to my child?
Provided that the child has been given the dose as recommended on the bottle, you do not need to worry; but if you have concerns about the condition of your child, you should contact a health professional - for example, by calling NHS Direct on 0845 46 47.

Are cough and cold medicines still safe to use in children over 2 years?
Cough and cold preparations are considered safe when used at the recommended doses. To ensure that these medicines are used safely the following advice should be followed:

The instructions on the medicine about suitable age groups and appropriate doses should be followed carefully, taking into account the most recent advice.

Cough and cold medicines may contain more than one active ingredient and different brands may contain the same active ingredients. These are listed on the medicine packaging. Parents should not give a child more than one cough and cold medicine, as they may contain the same active ingredient(s) and the maximum recommended dose(s) for the drug(s) may be exceeded.

The medicine should be administered carefully in accordance with the manufacturer's instructions to ensure the child does not receive more than the maximum dose.

Can I still give my child ibuprofen or paracetamol?
You can give your child ibuprofen or paracetamol, in accordance with the instructions on the label, provided the child is not taking any other medicine which contains these ingredients.