File photo: A medicine shop NEW DELHI: Parents of children below four years will now have to be more cautious about giving them combination medicines for cold symptoms, with the Centre restricting the manufacture, sale and distribution of all fixed-dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride.The government has said these combinations may pose risks to children below four and that safer alternatives are available. Manufacturers have been ordered to carry a prominent warning on the drug label, package insert and promotional material stating: “Fixed Dose Combination shall not be used in children below four years of age.”Dr Rommel Tickoo, senior director, internal medicine, Max hospital, said, “In children below four years, combination cold medicines containing chlorpheniramine and phenylephrine can cause excessive drowsiness or agitation, rapid heartbeat and, in some cases, serious adverse effects. Since these medicines offer limited benefit for a common cold, parents should prefer safer measures such as saline nasal drops, adequate fluids and honey for children above one year.”The move is the latest step in a regulatory review that dates back to 2023, when concerns were raised over the use of the combination in young children. The issue was re-examined in 2024 with paediatricians, with DTAB recommending that the warning apply to all formulations. Join conversationView All Comments →Share your thoughts in the commentsInsightfulAgreeDisagreeSkepticalConcerningPromisingWorth ReadingBig DevelopmentPost CommentBe respectful · TOI community guidelinesThe Centre subsequently imposed restrictions in April 2025, and DTAB revisited the matter in February 2026, agreeing to extend the restriction to all formulations.The latest notification now covers all such formulations, including those manufactured or imported and marketed in India.The decision follows recommendations of an Expert Committee constituted by the Health Ministry and the Drugs Technical Advisory Board (DTAB). DTAB, at its February 16, 2026 meeting, agreed that the formulations should not be used in children below four.Issued under Section 26A of the Drugs and Cosmetics Act, 1940, the notification came into force upon publication in the Official Gazette.Get the latest India News and Live updates. Download the TOI app.About the AuthorAnuja JaiswalAnuja Jaiswal is a Senior Assistant Editor at The Times of India, with an impressive 18-year career in narrative journalism. She specializes in health and heritage reporting, expertly simplifying complex health information to make it engaging and understandable for readers. Her deep dives into heritage topics are well-researched, resulting in captivating narratives that resonate with her audience. Over the years, she has worked in Chandigarh, Chhattisgarh and West UP, gaining diverse on-ground experience that shapes her storytelling.Read MoreEnd of ArticleFollow Us On Social MediaVideosYoutuber Ajeet Bharti Lists 4 Big Demands At Jantar Mantar, Calls For Reservation Reform And MeritPM Modi Meets BJP’s New Team At Delhi HQ As Party Pushes Vande Mataram Legacy Nationwide‘48 Hours Or Sit-In’: Abhijeet Dipke Warns After CJP Team Allegedly Attacked Near Jaipur SchoolIndiGo Delhi-Gorakhpur Flight Makes Two Go-Arounds, Suffers Tail Impact During Third LandingPunjab Gangster’s Thar Rams Coconut Seller During Police Chase, CCTV Captures Entire IncidentRajasthan School Crisis: 611 Schools Lack Buildings, Thousands More Face Unsafe InfrastructureBJP Builds Gen Z Team As Rahul Gandhi Takes Student Outreach To Pune With ‘Chhatron Ki Goonj’SC-ST Act Repeal, Creamy Layer Demand: Protesters Seek Major Overhaul Of India’s Reservation SystemBCI Chief Manan Mishra Rejects CJP’s Resignation Demand, Says Lawyers Can Never Be CockroachesH1N1 Cases Rise In Delhi: Health Minister Nadda Holds Meet, Reviews Swine Flu Situation123Photostories5 signs you have a TOXIC wifeNayanthara’s ivory saree, gold choker and gajra are a masterclass in minimal but classic Onam style10 meaningful baby boy names inspired by positive human qualities10 famous foods that became popular when people had very little moneyFrom Ed Sheeran to Elton John: Stars who stay away from technologyBandhani to Leheriya: Indian textiles fashion lovers often mistake for each other7 telltale signs your ‘office bestie’ is quietly competing with youHair fall getting worse every monsoon? 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File photo: A medicine shop NEW DELHI: Parents of children below four years will now have to be more cautious about giving them combination medicines for cold symptoms, with the Centre restricting the manufacture, sale and distribution of all fixed-dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride.The government has said these combinations may pose risks to children below four and that safer alternatives are available. Manufacturers have been ordered to carry a prominent warning on the drug label, package insert and promotional material stating: “Fixed Dose Combination shall not be used in children below four years of age.”Dr Rommel Tickoo, senior director, internal medicine, Max hospital, said, “In children below four years, combination cold medicines containing chlorpheniramine and phenylephrine can cause excessive drowsiness or agitation, rapid heartbeat and, in some cases, serious adverse effects. Since these medicines offer limited benefit for a common cold, parents should prefer safer measures such as saline nasal drops, adequate fluids and honey for children above one year.”The move is the latest step in a regulatory review that dates back to 2023, when concerns were raised over the use of the combination in young children. The issue was re-examined in 2024 with paediatricians, with DTAB recommending that the warning apply to all formulations. Join conversationView All Comments →Share your thoughts in the commentsInsightfulAgreeDisagreeSkepticalConcerningPromisingWorth ReadingBig DevelopmentPost CommentBe respectful · TOI community guidelinesThe Centre subsequently imposed restrictions in April 2025, and DTAB revisited the matter in February 2026, agreeing to extend the restriction to all formulations.The latest notification now covers all such formulations, including those manufactured or imported and marketed in India.The decision follows recommendations of an Expert Committee constituted by the Health Ministry and the Drugs Technical Advisory Board (DTAB). DTAB, at its February 16, 2026 meeting, agreed that the formulations should not be used in children below four.Issued under Section 26A of the Drugs and Cosmetics Act, 1940, the notification came into force upon publication in the Official Gazette.Get the latest India News and Live updates. Download the TOI app.About the AuthorAnuja JaiswalAnuja Jaiswal is a Senior Assistant Editor at The Times of India, with an impressive 18-year career in narrative journalism. She specializes in health and heritage reporting, expertly simplifying complex health information to make it engaging and understandable for readers. Her deep dives into heritage topics are well-researched, resulting in captivating narratives that resonate with her audience. Over the years, she has worked in Chandigarh, Chhattisgarh and West UP, gaining diverse on-ground experience that shapes her storytelling.Read MoreEnd of ArticleFollow Us On Social MediaVideosYoutuber Ajeet Bharti Lists 4 Big Demands At Jantar Mantar, Calls For Reservation Reform And MeritPM Modi Meets BJP’s New Team At Delhi HQ As Party Pushes Vande Mataram Legacy Nationwide‘48 Hours Or Sit-In’: Abhijeet Dipke Warns After CJP Team Allegedly Attacked Near Jaipur SchoolIndiGo Delhi-Gorakhpur Flight Makes Two Go-Arounds, Suffers Tail Impact During Third LandingPunjab Gangster’s Thar Rams Coconut Seller During Police Chase, CCTV Captures Entire IncidentRajasthan School Crisis: 611 Schools Lack Buildings, Thousands More Face Unsafe InfrastructureBJP Builds Gen Z Team As Rahul Gandhi Takes Student Outreach To Pune With ‘Chhatron Ki Goonj’SC-ST Act Repeal, Creamy Layer Demand: Protesters Seek Major Overhaul Of India’s Reservation SystemBCI Chief Manan Mishra Rejects CJP’s Resignation Demand, Says Lawyers Can Never Be CockroachesH1N1 Cases Rise In Delhi: Health Minister Nadda Holds Meet, Reviews Swine Flu Situation123Photostories5 signs you have a TOXIC wifeNayanthara’s ivory saree, gold choker and gajra are a masterclass in minimal but classic Onam style10 meaningful baby boy names inspired by positive human qualities10 famous foods that became popular when people had very little moneyFrom Ed Sheeran to Elton John: Stars who stay away from technologyBandhani to Leheriya: Indian textiles fashion lovers often mistake for each other7 telltale signs your ‘office bestie’ is quietly competing with youHair fall getting worse every monsoon? Expert explains what humidity, sweat and rainwater are doing to your scalp and how to prevent itFrom a net worth of over Rs 2,000 crores to a lavish house in Delhi: Shalini Passi’s luxurious lifestyleHow to wash citrus fruits properly to remove wax, germs and dirt123Hot PicksTCS laptop monitoring softwareTNEA counselling3 year practice ruleCM Revanth ReddyWeather tomorrowNEET UG 2026US-Canada tradeSIM card rulesBank holiday todayTop TrendingMumbai Rape AirhostessReservation Hatao AndolanLucknow Double Murder SuicideMadhapur Road AccidentMaharashtra Hill TragedyAbhijeet DipkeJharkhand Factory FireRahul GandhiBengaluru RapidoAston Martin Crash


Cold medicines for under-4s face curbs over safety concerns
File photo: A medicine shop

NEW DELHI: Parents of children below four years will now have to be more cautious about giving them combination medicines for cold symptoms, with the Centre restricting the manufacture, sale and distribution of all fixed-dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride.The government has said these combinations may pose risks to children below four and that safer alternatives are available. Manufacturers have been ordered to carry a prominent warning on the drug label, package insert and promotional material stating: “Fixed Dose Combination shall not be used in children below four years of age.”Dr Rommel Tickoo, senior director, internal medicine, Max hospital, said, “In children below four years, combination cold medicines containing chlorpheniramine and phenylephrine can cause excessive drowsiness or agitation, rapid heartbeat and, in some cases, serious adverse effects. Since these medicines offer limited benefit for a common cold, parents should prefer safer measures such as saline nasal drops, adequate fluids and honey for children above one year.The move is the latest step in a regulatory review that dates back to 2023, when concerns were raised over the use of the combination in young children. The issue was re-examined in 2024 with paediatricians, with DTAB recommending that the warning apply to all formulations.

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