[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.55]

[Page 19-20]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 201--LABELING--Table of Contents
 
 Subpart B--Labeling Requirements for Prescription Drugs and/or Insulin
 
Sec. 201.55  Statement of dosage.

    Section 201.100(b)(2) requires that labels for prescription drugs 
bear a statement of the recommended or usual dosage. Since the dosage 
for some prescription drugs varies within extremely

[[Page 20]]

wide limits, depending upon the conditions being treated, it may not be 
possible in all cases to present an informative or useful statement of 
the recommended or usual dosage in the space available on the label or 
carton of the package. It is the view of the Food and Drug 
Administration that when such a situation prevails, compliance with this 
requirement would be met by a statement such as ``See package insert for 
dosage information'', where the detailed information is contained in 
such insert. However, if an informative, realistic, recommended or usual 
dosage can readily be set forth on the label, it should appear thereon.