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New Delhi, April 18, 2025: The Union Ministry of Health and Family Welfare has announced a significant restriction on the use of a widely available fixed-dose combination drug containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, prohibiting its use in children below the age of four. This decision comes following recommendations aimed at safeguarding the health of young children.
The advisory stems from evaluations conducted by the Subject Expert Committee (SEC) and the Drugs Technical Advisory Board (DTAB). According to the ministry’s gazette notification, the DTAB reviewed the combination drug and specifically advised against its use in the under-four age group, recommending the restriction under Section 26A of the Drugs and Cosmetics Act, 1940, which allows the government to regulate or restrict drugs in the public interest.
As a result of these recommendations, the Central Government has mandated that all formulations containing this combination drug must now carry a prominent warning label. The required text states: “This fixed-dose combination shall not be used in children below four years of age.” This warning must be displayed on labels, package inserts, and any promotional materials associated with the product during its manufacture, sale, and distribution within India.
The notification states, “On the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to regulate by way of restriction the manufacture for sale, sale, and distribution for human use of the said drug in the country.”
General Precautions Remain for All Ages
While the specific restriction targets children under four, the Health Ministry also reiterated general precautions for older children and adults using medications containing Chlorpheniramine Maleate.
- Drowsiness: This is a common side effect. Patients are strongly advised against driving vehicles or operating heavy machinery after taking the medication.
- Alcohol: Consuming alcohol while taking this medication can worsen dizziness and should be avoided.
- Underlying Conditions: Individuals with pre-existing health issues such as liver or kidney disease, cardiovascular problems, glaucoma, asthma, prostate enlargement, or diabetes should use the drug with caution and preferably under medical supervision.
- Drug Interactions: This combination may interact negatively with other medications, including monoamine oxidase inhibitors (MAOIs), blood pressure drugs, antidepressants, and certain asthma medications. Patients should inform their doctor about all medications they are currently taking.
- Pregnancy and Breastfeeding: Women who are pregnant or breastfeeding are advised to consult a healthcare professional before using this drug combination.
The ministry emphasized that even for children aged four and above, the drug should ideally be used only when specifically prescribed by a physician.
Disclaimer: This news article is based on information released by the Union Ministry of Health and Family Welfare, India. It is intended for informational purposes only and does not constitute medical advice. Always consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment,1 especially concerning medications for children. Do not use this information to diagnose or treat a health problem or disease.
