Warning: Children Under Two should not be given Cough and Cold Medicines
Please attribute to Dr Stewart Jessamine, Interim Manager Medsafe.
Cough and cold medicines should never be given to children aged less than two years of age and when given to older
children extra care should be taken.
The warning issued here follows similar warnings in the United States.
An expert review, completed late last year, found that there was no evidence that cough and cold medicines reduce the
symptoms of cough and colds in children.
The Medsafe and Medicines Adverse Reactions Committee (MARC) also reviewed US reports of deaths and serious side effects
from accidental overdoses that occurred in children under two years.
There have been no similar reports in New Zealand, however, the National Poisons Centre has received a number of calls
about overdoses of cough and cold medicines in children under two years requiring medical attention.
Based on the evidence of harm and the absence of benefit, the MARC recommended that these medicines should not be used
by children under two years.
In line with action taken in the US, Medsafe is currently working towards strengthening the current warnings to indicate
that these medicines must not be used in children under two years under any circumstances. Currently most labels for
over-the-counter cough and cough medicines advise against use in children under two years except upon medical advice.
Medsafe advise parents:
Do not use cough and cold medicines in children aged under two years.
For children over two years:
If it is necessary to give a cough and cold product to a child, make sure that you read all labels and instructions
before doing so. If the product does not contain dose information for children, then it should not be used in children.
Do not give a child a larger dose than is recommended. Do not use the product more frequently than is recommended in the
labelling and instructions.
Take care not to unintentionally overdose your child. Note all the medicinal ingredients in the product, particularly if
you may be giving more than one product to a child. Be aware that many products contain the same medicinal ingredient(s)
and combined use could lead to overdose. Some over-the-counter medications used to control fever may also have medicinal
ingredients similar to those in other cough and cold products.
Because cough and cold medications often contain multiple ingredients, it is advised not to give more than one cough and
cold product to a child.
Talk to your doctor or healthcare practitioner if you have questions about the proper use of these products, dosing and
administration information, or the medicinal ingredients in the products you are using.
There is no cure for the common cold. Children will usually recover from coughs and colds in time on their own. The
common cold is a mild, viral infection that can be managed by rest, sufficient fluid intake and comfort measures.
In young children and babies, it is sometimes important to rule out serious illnesses (for example, pneumonia or other
infections) which may present with cold-like signs and symptoms; this is especially important if symptoms persist or if
the child?s condition deteriorates.
If you are concerned about your child?s health, the child should be brought to a healthcare practitioner for medical
evaluation.
Background:
Medsafe is the Ministry of Health?s drug regulatory arm. Medsafe assesses all medicines for their safety and
effectiveness.
The Medicines Adverse Reactions Committee (MARC) provides advice to the Minister of Health about medicine adverse
reactions and advises on action that should be taken.
Medsafe and the Medicines Adverse Reactions Committee (MARC), reviewed data on the safety and effectiveness of cough and
cold medicines when used in children on 13 December 2007.
It is estimated that there are more than 100 cough and cold medicines available in New Zealand. The following active
ingredients are currently used in cough and cold medicines in New Zealand: Expectorants (medicines that help a person
cough up mucus): guaifenesin Mucolytics (medicines that dissolve or disperse mucus): bromhexine Decongestants (medicines
that shrink swollen membranes in the nose): pseudoephedrine and phenylephrine Cough suppressants (medicines that act to
suppress cough reflex): dextromethorphan and pholcodine Sedating antihistamines (drugs that block some of the reaction
to histamines produced in the body eg clear blocked nose.
These drugs frequently cause sleepiness): doxylamine, brompheniramine, chlorpheniramine, tripolidine, promethazine and
diphenhydramine (NB this is also a cough suppressant)
ENDS