{"id":1016809,"date":"2026-08-22T10:04:11","date_gmt":"2026-08-22T10:04:11","guid":{"rendered":"https:\/\/www.europesays.com\/us\/1016809\/"},"modified":"2026-08-22T10:04:11","modified_gmt":"2026-08-22T10:04:11","slug":"government-restricts-fixed-dose-combinations-containing-2-chemical-compounds-for-young-children","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/1016809\/","title":{"rendered":"Government restricts fixed dose combinations containing 2 chemical compounds for young children"},"content":{"rendered":"<p><img decoding=\"async\" src=\"https:\/\/www.europesays.com\/us\/wp-content\/uploads\/2025\/06\/1x1_spacer.png\" alt=\"Image used for representational purposes. File\" title=\"Image used for representational purposes. File\" data-original=\"https:\/\/www.europesays.com\/us\/wp-content\/uploads\/2025\/06\/1x1_spacer.png\" class=\"lead-img\" fetchpriority=\"high\"\/><\/p>\n<p class=\"caption\">\n                    Image used for representational purposes. File<br \/>\n                                          | Photo Credit: Reuters\n                                      <\/p>\n<p>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 containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, mandating a clear warning that these medicines shall not be used in children below four years of age.<\/p>\n<p>Earlier, vide a notification dated April 15, 2025, the government had restricted certain fixed dose combinations (FDCs) containing the two chemical compounds, subject to the same age-specific warning.<\/p>\n<p><img src-template=\"https:\/\/th-i.thgim.com\/public\/incoming\/37z7c0\/article71107968.ece\/alternates\/SQUARE_80\/IMG_8th-syrup_2_1_MBAG09I0.jpg\" data-original=\"https:\/\/th-i.thgim.com\/public\/incoming\/37z7c0\/article71107968.ece\/alternates\/SQUARE_80\/IMG_8th-syrup_2_1_MBAG09I0.jpg\" alt=\"\" data-device-variant=\"SQUARE~SQUARE~SQUARE~SQUARE\" class=\"media-object lazy adaptive placeholder lazy\" width=\"100%\" height=\"100%\"\/><\/p>\n<p>The latest notification extends this requirement to all formulations containing these two ingredients.<\/p>\n<p>The decision followed recommendations by an expert committee and the Drugs Technical Advisory Board (DTAB).<\/p>\n<p>The government noted that the use of such combinations may pose risks to children below four years of age and that safer alternatives are available.<\/p>\n<p><img src-template=\"https:\/\/th-i.thgim.com\/public\/incoming\/r6z7cl\/article70134839.ece\/alternates\/SQUARE_80\/20251005208L.jpg\" data-original=\"https:\/\/th-i.thgim.com\/public\/incoming\/r6z7cl\/article70134839.ece\/alternates\/SQUARE_80\/20251005208L.jpg\" alt=\"\" data-device-variant=\"SQUARE~SQUARE~SQUARE~SQUARE\" class=\"media-object lazy adaptive placeholder lazy\" width=\"100%\" height=\"100%\"\/><\/p>\n<p>Manufacturers have been directed to clearly display the warning \u2013 \u201cFixed Dose Combination shall not be used in children below four years of age \u2013 on the label, package insert and promotional literature associated with these formulations.<\/p>\n<p>The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, and is effective from the date of its publication in the official gazette.<\/p>\n<p class=\"publish-time-new\"> Published &#8211; August 22, 2026 12:05 pm IST<\/p>\n","protected":false},"excerpt":{"rendered":"Image used for representational purposes. File | Photo Credit: Reuters In a significant step to safeguard the health&hellip;\n","protected":false},"author":3,"featured_media":1016810,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[34],"tags":[406912,210,1060,406911,406913,406910,67,132,68],"class_list":["post-1016809","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-chlorpheniramine-maleate","tag-health","tag-medication","tag-medicines-banned-for-children-india","tag-phenylephrine-hydrochloride","tag-restricted-medicines-india","tag-united-states","tag-unitedstates","tag-us"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/117138600042254891","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/1016809","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=1016809"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/1016809\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/1016810"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=1016809"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=1016809"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=1016809"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}