[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR209.10]

[Page 136]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 209_REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT--Table of Contents
 
                         Subpart B_Requirements
 
Sec.  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 Sec.  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 Sec.  209.11 must be no 
smaller than 10 points.