The use of an anti-cold fixed drug combination has been prohibited by the Indian drugs regulator Central Drugs Standard Control Organisation (CDSCO) to be used for children under the age of 4.
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This common cold fixed drug combination (FDC) is a cocktail of two drugs, chlorpheniramine maleate and phenylephrine.
This decision was made based on the recommendations of the Subject Expert Committee (SEC) which emphasised that this drug combination should not be used for children below four years of age.
All manufacturers of this common cold fixed-dose combination (FDC), containing chlorpheniramine maleate IP 2mg with phenylephrine HCL IP 5 mg per ml drops, have been directed to include a warning on the label and the package about the caution: “FDC should not be used in children below 4 years of age.”
The order by the regulator on the fixed-drug combination was issued on December 18 and made public on Wednesday.
All about this anti-cold fixed drug combination
This anti-cold drug combination contains chlorpheniramine maleate and phenylephrine. While chlorpheniramine maleate is an anti-allergic drug (antihistamine), phenylephrine is a decongestant.
According to Cleveland Clinic, this drug combination helps treat symptoms of common cold or sinus inflammation. It can help relieve runny nose, sneezing and congestion in the nose. However, this medicine will not treat an infection.
However, experts suggest that it should be consumed after consulting a medical professional.
