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Safety Information

Revised: 28 May 2013

Use of Cough and Cold Medicines in Children - Updated advice

Medsafe has continued its review of the use of cough and cold medicines in children with the assistance of the Cough and Cold Review Group. This Group assessed the available safety and efficacy data to support the use of cough and cold medicines in children.

The Group have recommended to Medsafe that oral cough and cold medicines containing the following substances should not be used in children under six years of age:

guaifenesin phenylephrine doxylamine
ipecacuanha brompheniramine promethazine
dextromethorphan chlorphenamine triprolidine
pholcodine diphenhydramine pseudoephedrine


Medsafe has accepted this recommendation and is working closely with the sponsors (pharmaceutical companies) to update the package labelling of the affected cough and cold medicines.

The Cough and Cold Review Group considered that the use of cough and cold medicines containing only bromhexine, or intra-nasal decongestants (such as oxymetazoline and xylometazoline) should remain restricted to adults and children two years of age and over.

Further information is available on the Medsafe website at the following links:
Further information on the Cough and Cold Review Group
Further information on the recommendations
Questions and Answers on over the counter cough and cold medicines

What is the common cold?

The common cold is a viral infection of the nose and throat that can be caused by several different viruses. It can also affect the sinuses and ears. The common cold is not the same as influenza (flu). Viruses that cause the common cold are different and tend to be less severe compared to those that cause the flu.

The common cold is a self limiting condition which means that it will resolve without treatment. Cold symptoms such as coughing, runny nose, sore throat and sneezing, usually appear one to three days after the virus enters the body and resolve spontaneously within seven to ten days. Sometimes a secondary infection, requiring consultation with a doctor can develop from the common cold (see 'Warning signs that a child has a serious infection').

The common cold is the most common infectious disease in the community. It is normal for a child to have the common cold up to eight times a year.

It is important to note that infection with the common cold may be different in children compared to adults due to differences in structure (anatomy).

Further information is available on the Medsafe website at the following links:
What should I do for my child when they have the common cold?
Warning signs that a child has a serious infection

Over-the-counter medicines for the common cold

Cough and cold medicines are designed to help reduce the symptoms of the common cold such as runny nose and cough. These medicines do not cure the infection.

There are a number of different substances contained in cough and cold medicines. Each substance aims to reduce certain symptoms of the common cold:

Substance type Expected Function Examples
Mucolytics/expectorants Loosen the mucus (phlegm) from the respiratory tract (nose, throat and lungs) to make it easier to expel bromhexine
guaifenesin
ipecacuanha
Antitussives Decrease the urge to cough dextromethorphan
pholcodine
Nasal decongestants Reduce the amount of fluid going to the nose (runny nose) and reduce swelling of the inside of the nose (blocked nose) oxymetazoline
phenylephrine
pseudoephedrine
xylometazoline
Antihistamines* Reduce symptoms of allergy. The effects on the symptoms of the common cold are unclear brompheniramine
chlrophenamine
diphenhydramine
doxylamine
promethazine
triprolidine

* The use of antihistamines for allergy was not considered by the Group and is not affected by these recommendations.

A list of the cough and cold medicines approved for use in New Zealand is available on the Medsafe website at the following link:
List of affected medicines

When will these changes happen?

Medsafe is working closely with the sponsors to update the package labelling for cough and cold medicines to warn against the use of these medicines in children under six years of age.

Medsafe will issue further advice as the recommendations of the Cough and Cold Review Group are implemented. During this time there may be differences in the information you receive from your pharmacist/doctor and the information on the medicine label. You should follow the advice that your pharmacist or doctor gives you.

Information on what other countries are doing is available on the Medsafe website at the following link:
What are other countries doing?