Limit of Paracetamol (Acetamenophen) in Fixed Dose Combinations

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.

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