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India Expands Under-Four Warning to All Chlorpheniramine–Phenylephrine Drug Combinations

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Courtroom-sketch editorial illustration of a stethoscope from a 2012 photograph, with model lettering omitted; symbolic healthcare equipment, not the device, treatment, patient or facility reported.
AI courtroom sketch of a stethoscope from a 2012 photograph, with model lettering omitted; symbolic healthcare equipment, not the device, treatment, patient or facility reported. Adapted from the credited reference. Stethoscope No.120.JPG — Tama998; CC0.

India's Health Ministry has required every fixed-dose formulation containing chlorpheniramine maleate and phenylephrine hydrochloride to warn that it must not be used in children younger than four. The warning must appear on labels, package inserts and promotional literature. The notification, published in the Gazette on August 21, followed the Drugs Technical Advisory Board's February 16 recommendation.

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