Objective: To analyze the information of over-the-counter drug (OTC) instructions of Chinese patent medicines in children

so as to improve the level of rational drug use in children and promote the standardization of drug instructions of Chinese patent medicines. Methods: Totally 1

441 instructions of 186 kinds of OTC Chinese patent medicines for children were collected

and adverse drug reactions

drug contraindications

precautions and drug interactions in children were investigated and analyzed. The sample instructions issued by the National Medical Products Administration (NMPA) was compared with OTC instructions of Chinese patent medicines

focusing on the missing items

unclear and different contents. Results: Of the 1

441 instructions

the total proportion of adverse drug reactions

drug contraindications

precautions

missing items and unclear contents of drug interactions were 94. 1%

85. 9%

16. 6% and 95. 0%

respectively. There were differences between the instructions of 86 kinds of circulating drugs and the sample instruction

the difference rate was 47. 0%. Conclusion: At present

the content of OTC instructions of Chinese patent medicines for children is not complete

and the phenomenon of missing items and unclear expression is serious. Relevant departments should urge the declaration of enterprises to further improve the specification of non-standard drug instructions

so as to provide reliable legal basis for the clinical rational drug use.