CDSCO (India)
REGULATION
2026.08.18 S.O. 4595(E)_Prohibition of all formulations of FDC containing Chlorpheniramine Maleate and Phenylephrine HCl in children below four years of age
Published: 8/18/2026Detected: 9/4/2026
Summary preview
Prohibits all fixed-dose combination (FDC) formulations containing chlorpheniramine maleate and phenylephrine HCl from being used in children below four years of age, reflecting a targeted pediatric safety risk.
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Create free accountpediatrics
respiratory
safety
labeling
#CDSCO
#S.O. 4595(E)
#fixed-dose combination
#chlorpheniramine maleate
#phenylephrine HCl
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