Abstract: Objective To provide reference for the standardization of specifications in package inserts of Chinese patent medicine (CPM). Methods The package inserts of two hundred and three types of CPM which were prescribed in the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine between January 1, and June 30, in 2020 were collected. The problems with labeling of those package inserts were compared and analyzed according to the People's Republic of China (2020 edition)（ChP). Results Among the two hundred and three specifications of CPM, only one mentioned the incompatibility of drugs and seven presented antagonistic ingredients. The package inserts of twenty-three specifications mentioned syndrome type contraindications, five of which were inconsistent with the ChP. Fifty-seven specifications contained pregnancy contraindication labels, which were inconsistent with the ChP in five cases. In addition, there were twenty-two specifications that contained diet taboos, thirteen of which differed from those of the ChP. Conclusion Some package inserts of CPM have substandard labels of contraindications that show poor consistency with the ChP. Drug regulatory departments should continue to strengthen supervision and management. Meanwhile, it is necessary to enhance the quality of prescriptions and to improve the contents of the (ChP).

Key words: Chinese patent medicine, package inserts, contraindications, Pharmacopoeia of the People's Republic of China