---
kind: "section"
citation: "21 C.F.R. § 209.10"
title: "21"
number: "209.10"
heading: "Content and format of the side effects statement."
url: "https://uscodex.org/cfr/21/209.10"
---

# §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](/cfr/21/505.md) 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)](/cfr/21/209.11.md?p=b-1) and [(b)(2)](/cfr/21/209.11.md?p=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)](/cfr/21/209.11.md?p=b-3), [(b)(4)](/cfr/21/209.11.md?p=b-4), and [(b)(5)](/cfr/21/209.11.md?p=b-5) of § 209.11 must be no smaller than 10 points.

## Notes

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371; 42 U.S.C. 241.

### Source

Source: 73 FR 404, Jan. 3, 2008, unless otherwise noted.