New Delhi, Aug 22: The Centre has taken another step towards strengthening medicine safety for young children by extending restrictions on fixed-dose combination medicines containing chlorpheniramine maleate and phenylephrine hydrochloride for children below four years of age.
The government has directed manufacturers to clearly display a warning on the label, package insert and promotional material stating that the combination should not be used in children below four years. The measure applies to all formulations containing the two ingredients.
The decision follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB). The government said the combination could pose risks to children in this age group and that safer alternatives are available.
The strengthened warning is aimed at helping parents, caregivers and healthcare professionals make safer choices when treating young children for cold and allergy-related symptoms. Clear information on medicine packaging can also help prevent accidental or inappropriate use.
The latest step builds on an earlier government action concerning certain formulations of the same combination. The new notification extends the safety requirement to all formulations, providing a more consistent safeguard for children below four years.
The move highlights the government’s focus on child-centred healthcare and responsible use of medicines. By strengthening safeguards and ensuring that important safety information is clearly communicated, the measure seeks to support safer treatment practices for young children.
For parents and caregivers, the advice remains straightforward: check the ingredients and age-related warnings on medicines and consult a healthcare professional before giving medication to a child below four years.
The initiative is ultimately aimed at ensuring that young children receive safer, more appropriate and carefully considered medical care.