MSA COUGH AND COLD MEDICINES

The Medicines Control Council (MCC) of South Africa wishes to alert healthcare professionals that the use of oral cough and cold medicines containing certain ingredients is now contraindicated in children under the age of two years.

This decision is in line with international recommendations regarding the use of oral cough and cold medicines in children.

Based on the available information, the MCC decided to contraindicate the use of oral cough and cold medicines containing brompheniramine, chlorpheniramine, dextromethorphan, diphenhydramine, ephedrine, guaifenesin, ipecacuanha, phenylephrine, pholcodine and pseudoephedrine in children under the age of two years due to an unfavourable risk benefit profile of these medicines in this age group. This decision, however does not preclude the use of medicines containing antihistamines as a single agent when used for allergic reactions (hypersensitivity).


The manufacturers of these oral cough and cold medicines will be updating the product information to reflect the contraindication in children under the age of two years. This may however take some time to be fully implemented.

The MCC urges healthcare professionals to heed the following warnings and advice before recommending the use of cough and cold medicines in children:

  • Cough and cold medicines containing the above listed ingredients should not be prescribed or used in children under the age of two years.

For children over the age of two years

  • The referred ingredients may only be prescribed by a doctor or pharmacist.
  • The concurrent use of two or more different cough and cold products in the same patient should be avoided as these can result in serious adverse effects.
  • The dosing instructions in the package insert should be read carefully to ensure that the prescribed dosage is within the recommended dosage range and frequency for the patient’s age and/or weight.

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