Abstract: The requirements for warnings and precautions, contraindications and boxed warning of labeling are described specifically in FDA's "Guidance for Industry Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products-Content and Format". There is no similar guidance in our country. The primary content of it is introduced in this article. It is expected to assist the writers and reviewers of labeling. Key words: Food and Drug Administration; guidance; labeling for prescription drug; warnings and precautions; contraindications; boxed warning