Code of Federal Regulations Title 21. Food and Drugs § 21.209.10 Content and format of the side effects statement

(a) Content. The side effects statement provided with each prescription drug product approved under section 505 of the act must read:  “Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.”

(b) Format. The side effects statement must be in a single, clear, easy-to-read type style. The letter height or type size used for the side effects statement in accordance with paragraphs (b)(1) and (b)(2) of § 209.11 must be no smaller than 6 points (1 point = 0.0138 inch). The letter height or type size for the side effects statement under paragraphs (b)(3), (b)(4), and (b)(5) of § 209.11 must be no smaller than 10 points.