Health Ministry Restricts All Cold Medicine FDCs for Children Below 4
The Union Health Ministry has issued a notification restricting the manufacture, sale, and distribution of all fixed-dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride. These medicines, commonly used in cold and allergy preparations, must now carry a clear warning that they shall not be used in children below four years of age.
The latest notification expands an earlier restriction that applied only to certain FDCs containing these two ingredients. Now, the age-specific warning is mandatory for every formulation that combines chlorpheniramine maleate, an antihistamine used to relieve runny nose and sneezing, and phenylephrine hydrochloride, a decongestant that reduces nasal blockage.
The decision follows recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB), the government's top advisory body on drug regulation. The health ministry noted that the use of such combinations may pose risks to children below four years and that safer alternatives are available.
Manufacturers have been directed to display the warning prominently on the label, package insert, and promotional literature. The prescribed text reads: “Fixed Dose Combination shall not be used in children below four years of age.”
The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health. It takes effect from the date of publication in the Official Gazette.
The move comes amid heightened global scrutiny of cough-and-cold medicines in young children. Paediatricians and regulatory agencies have expressed concern that multi-ingredient medicines can be difficult to dose accurately in children, increasing the risk of adverse effects. Chlorpheniramine can cause marked drowsiness or, in some children, excitability. Phenylephrine can affect heart rate and blood pressure. Meanwhile, evidence that such combinations meaningfully relieve symptoms of an uncomplicated cold in children is limited.
In 2023, India had already required warnings on certain formulations containing these ingredients. In 2025, the government formally restricted their use in combination for children below four. The latest notification extends that restriction to all FDC formulations with chlorpheniramine and phenylephrine, removing any ambiguity about which products are covered.
Several countries, including the United States and Australia, have also adopted age restrictions or other safeguards for paediatric cough-and-cold medicines. The Indian government's action aligns with these international trends while responding to domestic expert advice.
The restriction applies to all stakeholders, including manufacturers, distributors, and retailers. Any formulation covered by the notification that is found without the required warning will be considered in violation of the Drugs and Cosmetics Act. The ministry expects compliance to be immediate.
Parents and caregivers are advised to consult a qualified doctor before giving any cold medicine to a child under four. The government has not advised against the use of these medications in older children or adults when prescribed appropriately.
