Giving cough syrup to your toddler? Big red warning on label may soon flag risks for kids under 4
The move follows continued concern that these medicines are still being prescribed to very young children despite earlier advice.
- Sep 19, 2026,
- Updated Sep 19, 2026 12:52 PM IST
Amid continuing concern over medicines being given to infants and toddlers, India’s drug regulator is considering mandatory labelling changes for cough syrups to discourage their use in children below four years of age. The proposal also calls for a pictorial depiction of school-age children on the label to reinforce that the medicine is intended for older children and not infants and toddlers, , The Economic Times reported.
According to the proposal, the following warning may be prominently displayed in red on the bottle label: "WARNING: Cough syrup should not be used in children below 4 years of age". The proposal has been placed before the Drugs Consultative Committee for deliberation and seeks an amendment to Rule 96 of the Drugs Rules, 1945.
What the proposed label change says
In addition to the red warning, the proposal says a pictorial depiction of school-age children may be included on the bottle label to reinforce that the product is intended for older children and to discourage its use in children below the specified age. Any change would follow deliberation by the Drugs Consultative Committee and the regulatory process required for amending the rules.
Why the issue has come up again
The move comes amid continued concerns over the prescribing of cough syrups to infants and young children, despite a Directorate General of Health Services advisory issued in October 2025. The DGHS had called for judicious prescribing and dispensing of cough and cold medicines in paediatric care and specifically advised that such medicines should not be prescribed or dispensed to children below two years of age.
Despite that advisory, a complaint was later received regarding the continued prescribing of cough syrups to infants below two years of age. "The practice has continued even after the DGHS issued specific directions against it in October 2025," said a person familiar with the matter.
What CDSCO and ICMR said
The complaint was deliberated by an internal technical committee of the Central Drugs Standard Control Organisation in April 2026. The committee recommended discussing the matter with the Indian Council of Medical Research to ascertain whether the research body had any proposals concerning cough syrups in the paediatric population. It also recommended a stakeholder consultation on the regulatory and marketing feasibility of changes to the labelling.
ICMR, however, said it was not undertaking any work on cough syrup labelling, according to the report. "Cough syrups are among the most commonly prescribed and over-the-counter purchased medicines in India, and their use in very young children has long been a concern among health experts," said another person familiar with the matter.
Wider backdrop to the proposal
The proposed broader labelling change comes shortly after the government imposed restrictions on all fixed-dose combinations 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 fixed-dose combinations 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.
For now, the proposal before the Drugs Consultative Committee seeks a wider warning on cough syrup bottles and a school-age image on labels, as regulators respond to continued concern over the prescribing of these medicines to very young children despite earlier advice against such use.
Amid continuing concern over medicines being given to infants and toddlers, India’s drug regulator is considering mandatory labelling changes for cough syrups to discourage their use in children below four years of age. The proposal also calls for a pictorial depiction of school-age children on the label to reinforce that the medicine is intended for older children and not infants and toddlers, , The Economic Times reported.
According to the proposal, the following warning may be prominently displayed in red on the bottle label: "WARNING: Cough syrup should not be used in children below 4 years of age". The proposal has been placed before the Drugs Consultative Committee for deliberation and seeks an amendment to Rule 96 of the Drugs Rules, 1945.
What the proposed label change says
In addition to the red warning, the proposal says a pictorial depiction of school-age children may be included on the bottle label to reinforce that the product is intended for older children and to discourage its use in children below the specified age. Any change would follow deliberation by the Drugs Consultative Committee and the regulatory process required for amending the rules.
Why the issue has come up again
The move comes amid continued concerns over the prescribing of cough syrups to infants and young children, despite a Directorate General of Health Services advisory issued in October 2025. The DGHS had called for judicious prescribing and dispensing of cough and cold medicines in paediatric care and specifically advised that such medicines should not be prescribed or dispensed to children below two years of age.
Despite that advisory, a complaint was later received regarding the continued prescribing of cough syrups to infants below two years of age. "The practice has continued even after the DGHS issued specific directions against it in October 2025," said a person familiar with the matter.
What CDSCO and ICMR said
The complaint was deliberated by an internal technical committee of the Central Drugs Standard Control Organisation in April 2026. The committee recommended discussing the matter with the Indian Council of Medical Research to ascertain whether the research body had any proposals concerning cough syrups in the paediatric population. It also recommended a stakeholder consultation on the regulatory and marketing feasibility of changes to the labelling.
ICMR, however, said it was not undertaking any work on cough syrup labelling, according to the report. "Cough syrups are among the most commonly prescribed and over-the-counter purchased medicines in India, and their use in very young children has long been a concern among health experts," said another person familiar with the matter.
Wider backdrop to the proposal
The proposed broader labelling change comes shortly after the government imposed restrictions on all fixed-dose combinations 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 fixed-dose combinations 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.
For now, the proposal before the Drugs Consultative Committee seeks a wider warning on cough syrup bottles and a school-age image on labels, as regulators respond to continued concern over the prescribing of these medicines to very young children despite earlier advice against such use.