New Delhi: The government has imposed restrictions on the manufacture, sale and distribution of all fixed dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, directing manufacturers to carry a clear warning that these medicines must not be used in children below four years of age.
The latest regulatory action expands an earlier notification issued on April 15, 2025, which had restricted certain FDCs containing the two ingredients and required the same age-specific warning.
The decision is aimed at strengthening safety measures for young children and ensuring that medicines containing the combination are not used in children below the specified age.
Warning mandatory on medicine packaging
Under the latest notification, manufacturers have been directed to prominently display the warning: “Fixed Dose Combination shall not be used in children below four years of age.”
The warning must appear on the medicine label, package insert and promotional literature associated with the formulations.
By extending the requirement to all formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, the government has widened the scope of the earlier restriction.
The move is intended to ensure that the age-related safety information is clearly communicated to healthcare professionals, parents, caregivers and other consumers.
Decision follows expert recommendations
The government said the latest decision was taken following recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB).
Authorities noted that the use of such combinations may pose risks to children below four years of age. The government also pointed out that safer alternatives are available.
The regulatory decision reflects the importance of considering age-specific safety when medicines are formulated and prescribed for young children.
What are Chlorpheniramine and Phenylephrine?
Chlorpheniramine Maleate is an antihistamine used to manage allergy-related symptoms, while Phenylephrine Hydrochloride is a decongestant commonly used to relieve nasal congestion.
Both ingredients may be included together in medicines intended to provide relief from symptoms associated with colds and allergies.
However, medicines used in young children require particular caution because their response to drugs can differ from that of adults. The appropriate medicine and dosage can depend on factors such as age, symptoms and individual health circumstances.
The government’s latest notification specifically establishes that these FDCs should not be used in children below four years of age.
Earlier notification in April 2025
The government had previously issued a notification on April 15, 2025, restricting certain fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
That notification also required the formulations to carry a warning against their use in children below four years.
The latest notification extends this requirement to all formulations containing the two specified ingredients.
The expanded restriction is intended to provide a more comprehensive regulatory safeguard and prevent the use of such combinations among children in the age group identified by the authorities as being at risk.
Manufacturers must update product information
Manufacturers covered by the notification will have to ensure that the prescribed warning is clearly displayed across relevant product information.
This includes labels placed on medicine packaging, package inserts supplied with the products and promotional literature used in connection with the formulations.
The requirement is particularly important because product information is one of the primary ways in which consumers and healthcare professionals are informed about age-specific restrictions and precautions.
Companies will therefore need to ensure that the required warning is incorporated into their relevant materials in accordance with the notification.
Action under Drugs and Cosmetics Act
The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940.
The provision allows the government to take regulatory action concerning the manufacture, sale or distribution of drugs when such measures are considered necessary in the public interest.
The latest restriction forms part of the government’s broader regulatory oversight of medicines and their safe use.
The notification is effective from the date of its publication in the official gazette.
What parents should know
The restriction specifically concerns children below four years of age. Parents and caregivers should not give medicines containing the specified FDC to children in this age group without appropriate medical advice.
Cold, cough and allergy symptoms in young children can have different causes, and treatment should be based on the child’s individual circumstances. The government’s statement that safer alternatives are available further underlines the importance of seeking appropriate medical guidance rather than using combination medicines without professional advice.
The latest move also highlights the importance of reading medicine labels and package inserts carefully, particularly when medicines are intended for children.
With the new notification, all formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride will be subject to the prescribed age-related warning, strengthening safeguards around their use in young children.