Cough syrups still being given to very young children; red warning for under-4s proposed
Indian health regulators are proposing stricter labeling for cough syrups to prevent their use in children under four years old. This follows reports that the medication is still being prescribed to infants despite previous advisories.
Why it matters
Ensuring pediatric safety through clear medical labeling is a critical public health issue to prevent accidental misuse of over-the-counter drugs.
The use of cough syrups for children under the age of four continues despite the drug regulator’s guidelines. Now, India’s drug regulator is examining a proposal to make changes to cough syrup labels to discourage their use in children under four years of age.The proposed changes include a visual showing school-age children on the packaging, intended to make it clear that the medicine is meant for older children rather than infants and toddlers.The proposal comes amid continuing concerns over cough syrups being prescribed to infants and young children, despite an October 2025 advisory from the directorate general of health services (DGHS) advising against the practice.New warning on cough syrup bottlesAccording to the proposal seen by ET, the bottle label could prominently carry a red warning stating: “WARNING: Cough syrup should not be used in children below 4 years of age”.It further proposes that “Additionally, a pictorial depiction of school-age children…
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