Abstract: OBJECTIVE To sort out the chemical drugs for children in China's over-the-counter(OTC) drugs catalogue and analyze the drug categories and the specification of the instructions, so as to find out the key points that lead to the risk of drug use, and put forward suggestions for improvement. METHODS According to the sample of OTC drugs instructions published on the website of the National Medical Products Administration, as well as the results of clinical expert investigation and literature, the OTC drugs catalog of children's chemical drugs was determined and classified, and the investigate the standardization and consistency of the instructions. RESULTS There were 267 kinds of OTC drugs for children sorted out, involving 18 kinds of diseases. A considerable proportion of the instructions were incomplete and nonstandard, and there were few kinds of drugs for respiratory and digestive diseases. CONCLUSION The preparation and publicity of children OTC drugs instructions should be standard, the research and development of children's OTC drugs should be strengthened, the training of pharmacy employees should be strengthened, and ensure the rational and safe use of children's OTC drugs.