Risks of OTC Cough Syrup for Children Below 4 Years

It is issuing a notification to its 40,000 members, explicitly instructing them not to sell FDC cough syrup for children below four years.

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Cough Syrup

In a recent development, doctors in various cities are cautioning parents against purchasing Fixed Drug Combinations (FDC) cough syrup over the counter for children below four years.

This advisory comes in the wake of a mandate issued by the Central Drugs Standard Control Organization (CDSCO) of India.

DSCO’s Mandate

The CDSCO’s directive underscores the potential risks associated with FDC cough syrups, emphasizing that these medications should not be used in children below four years of age.

This regulatory move aims to enhance safety standards and protect the health of the youngest members of our society.

The FDC Cough Syrup

These seemingly harmless cough syrups often contain a combination of two drugs: chlorpheniramine maleate and phenylephrine.

While the former is an antiallergy drug, the latter acts as a decongestant. One popular brand, Maxtra, is commonly purchased over the counter by parents.

Popular Brands and Their Prevalence

Maxtra and similar formulations are prevalent in the market, leading to widespread accessibility.

The ease of purchase without a prescription raises concerns, considering the potential dangers associated with these medications.

Alarming Incidents

Disturbing reports have surfaced, indicating that children under two years old have been rushed to hospitals due to adverse reactions such as convulsions and rapid heart rates after consuming FDC cough syrup.

Insights from Clinical Pharmacologists

Clinical pharmacologists, such as Shamo S Samajdar, stress the delicate balance required when medicating young children.

The recent directive, according to Samajdar, is a prudent measure to safeguard the youngest and most vulnerable patients from potential harm.

CDSCO’s Directive

The CDSCO’s directive not only prohibits the sale of FDC cough syrup for children below four years but also serves as a crucial step in aligning the medical community with safety-focused practices.

The Warning Label Requirement

Manufacturers are now mandated to include a warning on FDC cough syrup packaging, explicitly stating that the product should not be used in children below four years.

This ensures that potential risks are communicated clearly to the public.

West Bengal Chemists and Druggists Association’s Notice

The Bengal Chemists’ and Druggists’ Association (BCDA) in West Bengal is actively addressing this issue.

It is issuing a notification to its 40,000 members, explicitly instructing them not to sell FDC cough syrup for children below four years.

BCDA’s Notification to Members

Sajal Ganguly, the general secretary of BCDA, states that a restricted sale notice will be issued for the specific medicine.

Additionally, members are warned not to sell any cough syrup without a prescription. This proactive approach aims to eliminate confusion among pharmacy owners.

Pharmaceutical Companies’ Formulations

Rajendra Khandelwal of Dhanwantary Pharma sheds light on the specific formulation, indicating that it is prescribed by a select group of physicians.

This specialized use reduces the chances of indiscriminate sales as an over-the-counter product.

Limited Prescription and Specialized Use

Specialized doctors typically prescribe the specific formulation in emergency situations.

With limited prescriptions, the likelihood of the medicine being sold over the counter is significantly reduced, ensuring responsible usage.

Metro Pharma’s Stance

Despite concerns and queries from patients, some pharmacies, like Metro Pharma, have taken a proactive stance.

Somnath Ghosh of Metro Pharma mentions that they have ceased selling the medicine, awaiting official notifications.

Impact on Sales and Patient Queries

The cessation of sales by certain pharmacies, including Metro Pharma, indicates a potential shift in the market.

However, the impact on sales and patient queries remains to be fully understood as the situation develops.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.


  1. Is it safe to use any cough syrup for young children without a prescription?
    • No, it is not safe. Always consult with a healthcare professional before giving any medication to young children.
  2. Why has the CDSCO specifically targeted FDC cough syrups for children below four years?
    • The CDSCO has identified potential risks associated with these medications in young children and aims to protect their health through this directive.
  3. What should parents do if they already have FDC cough syrup at home for their young children?
    • It is advisable to consult with a healthcare professional for guidance. Discarding the medication and seeking an alternative under professional supervision is recommended.
  4. Are there alternative medications available for young children’s cough and cold symptoms?
    • Yes, there are alternative medications that are deemed safe for children. However, professional advice is essential to determine the most suitable option.
  5. How can parents ensure the safety of over-the-counter medications for their children?
    • Always read labels carefully, follow dosage instructions, and consult with healthcare professionals if there are any doubts or concerns.

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