Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com
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Last Updated on May 14, 2024 by The Health Master
Paracetamol
Limit of the strength of Paracetamol was limited to 325 mg. per tablet/capsule in Prescription Combinations / Fixed Dose Combinations (FDC) by DCG(I) vide its circular dated 23.09.2011 and subsequent circular dated 04.04.2012.
As per these circulars:
Maximum Limit
• Maximum Limit of Paracetamol (Acetamenophen) should be upto 325 mg. per tablet/capsule in prescription combinations / Fixed Dose Combinations (FDC).
Box warning
• Box warning indicating “taking more than daily dose may cause serious liver damage or allergic reactions (e.g. swelling of face, mouth & throat, difficulty in breathing, itching or rash)” is mandatory to be printed on the label of FDCs containing Paracetamol.
Furthermore, in 46th meeting of Drugs Consultative Committee held on November 12-13, 2013, DCGI again issued a clarification about the limit of strength of Paracetamol in Fixed Dose Combinations (FDC) as under:
Maximum Limit with NSAID
• Maximum Limit of Paracetamol (Acetamenophen) should be upto 325 mg. per tablet/capsule with any Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) e.g. Paracetamol with Nimesulide, Diclofenac, Aceclofenac, Ibuprofen etc.
Example:
For example strength of Paracetamol in Fixed Dose Combination (FDC) with caffeine is allowed upto 500 mg per tablet/capsule but restricted to 325 mg. per tablet/capsule in Fixed Dose Combination (FDC) with Nimesulide (NSAID).
• Box warning as per previous circulars is mandatory to be printed on the label of FDCs containing Paracetamol.
• Fixed Dose Combinations (FDC) containing Paracetamol manufactured for export purpose are exempted from above conditions and can be manufactured after obtaining NOC from the Drugs Department.
