Centre restricts FDC cold medicines containing chlorpheniramine + phenylephrine for children below 4 years due to dosing errors and adverse-effect risks.
News: Centre expands restrictions on FDC cold medicines containing chlorpheniramine maleate + phenylephrine hydrochloride for children below 4 years.
About FDCs:
- FDCs → 2 or more active ingredients combined in fixed proportions in one dosage form.
- Restriction based on recommendations of Expert Committee + DTAB.
Why Restricted?
- Young children → higher risk of dosing errors + adverse effects.
- Multi-ingredient medicines → difficult to assess individual doses/effects.
- Mandatory warning: Not for use in children below 4 years.
Key Ingredients
- Chlorpheniramine → antihistamine → relieves runny nose & sneezing → may cause drowsiness/excitability.
- Phenylephrine → decongestant → relieves nasal congestion → may increase heart rate & blood pressure.