India restricts cough and cold syrups containing chlorpheniramine and phenylephrine
India has imposed restrictions on the sale, manufacture, and distribution of cough and cold syrups containing chlorpheniramine maleate and phenylephrine hydrochloride with a warning that they shall not be used in children younger than four.
The move comes after safety worries about these medicines in young children.
The notification is effective from the date of its publication in the official gazette and covers all versions with these ingredients.
Labels must carry under-four warning
From now on, every label, package insert, and ad for these medicines must clearly say: "Fixed Dose Combination shall not be used in children below four years of age."
This step is meant to describe the labeling requirement.
The wider restriction follows expert advice after an earlier partial restriction in 2025, so if you're caring for a young child, double-check those medicine labels!