(1) Reasons for Proposal

This Amendment aims to reflect foreign safety information and the deliberation results of the Central Pharmaceutical Affairs Council, by which the contents of caution in usage for medicine containing acetaminophen shall change, in the Standard Manufacturing Criteria for Drugs.

(2) Major Provisions

Include contents on the occurrence of severe adverse skin reactions and responsive measures, etc., in the warning section in the lable of caution in usage for acetaminophen, which is a compound ingredient in antipyretic analgesics (Chapter 2) and cold medicine (Chapter 3) (attached Table 1)