Cough syrups may soon get a red warning against use for children under 4

Drug regulator proposes prominent age warning and pictorial label on cough syrups; the move comes after continued concerns over use of such medicines in very young children

Cough syrup bottles may soon carry a prominent warning against their use in children below four years of age, with India’s drug regulator considering changes to the labelling requirements for such medicines, The Economic Times reported on Saturday.

 

The proposal, which has been placed before the Drugs Consultative Committee (DCC), calls for the warning to be displayed in red on the bottle label. It also proposes a pictorial depiction of school-age children to reinforce that the medicine is meant for older children and discourage its use in infants and toddlers, according to the ET report.

 

The proposed warning reads: “WARNING: Cough syrup should not be used in children below 4 years of age.”

  

The proposal seeks an amendment to Rule 96 of the Drugs Rules, 1945. Any change would follow deliberation by the DCC and the subsequent regulatory process.

 

The move comes amid continued concerns over the use of cough and cold medicines among young children. In October 2025, the Directorate General of Health Services (DGHS) had advised that cough and cold medicines should be prescribed and dispensed judiciously in paediatric care. It specifically advised against prescribing or dispensing such medicines to children below two years of age.

 

A subsequent complaint regarding the continued prescribing of cough syrups to infants below two years was examined by an internal technical committee of the Central Drugs Standard Control Organisation (CDSCO) in April 2026.

 

The committee recommended consulting the Indian Council of Medical Research (ICMR) on whether it had any proposals concerning cough syrups in the paediatric population. It also recommended stakeholder consultations on the regulatory and marketing feasibility of changes to cough-syrup labelling.

 

ICMR, however, said it was not undertaking any work on cough-syrup labelling, according to the ET report.

 

The proposed broader labelling change comes shortly after the government imposed restrictions on all fixed-dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride for use in children below four years.

 

In an August 22 notification, the health ministry said manufacturers of these FDCs must display a warning that they should not be used in children below four years of age on the label, package insert and promotional literature. The restriction followed recommendations from an expert committee and the Drugs Technical Advisory Board.

 

The proposed cough-syrup labelling requirement, if approved, would apply more broadly and would require a separate amendment to the Drugs Rules.