Centre extends ‘not for children below four’ warning to all chlorpheniramine-phenylephrine cold medicines
Key facts
- The Union Health Ministry tightened rules on fixed-dose combinations (FDCs) of chlorpheniramine maleate and phenylephrine hydrochloride.
- All such FDCs must now carry a warning: not to be used in children below four years.
- The warning must appear on the label, package insert and promotional material.
- The move followed advice from an expert committee and the Drugs Technical Advisory Board (DTAB).
- Medicines with only one of the two ingredients are not covered.
Why it matters
[Policy] Chlorpheniramine is an antihistamine and phenylephrine a decongestant. Small children face greater risk of side effects and overdose. Most childhood colds clear up on their own.
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