Earlier, vide notification dated 15 April 2025 [S.O. 1717(E)], the Government had restricted certain FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, subject to the same age-specific warning.
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Government Restricts Manufacture, Sale and Distribution of Fixed Dose Combinations Containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for Use in Children Below Four Years
In a significant step to safeguard the health and safety of young children, the Government has imposed restrictions on the manufacture, sale and distribution of all Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, mandating a clear warning that these medicines shall not be used in children below four years of age.
Source: Press Information Bureau (official). The summary and key points are quoted from that release; no AI is used. Check the source for the full text.
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The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health and is effective from the date of its publication in the Official Gazette.
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