Notification No.: S.O. 4595(E) dated August 18, 2026
Applicable Act/Rules: Drugs and Cosmetics Act, 1940
Applicable Section/Rule: Section 26A
Effective Date: August 19, 2026
The Central Government has restricted the manufacture, sale or distribution of all formulations of fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
The manufacturers of such drugs shall mention the following warning on the label, package insert or promotional literature:
“fixed dose combination shall not be used in children below four years of age”
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