[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR335.3]

[Page 230]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 335_ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of 
 
                      Subpart A_General Provisions
 
Sec.  335.3  Definitions.

    As used in this part:
    (a) Antidiarrheal. A drug that can be shown by objective measurement 
to treat or control (stop) the symptoms of diarrhea.
    (b) Diarrhea. A condition characterized by increased frequency of 
loose, watery stools (three or more daily) during a limited period (24 
to 48 hours), usually with no identifiable cause.
    (c) Travelers' diarrhea. A subset of diarrhea occurring in travelers 
that is most commonly caused by an infectious agent.

[68 FR 18881, April 17, 2003, as amended at 69 FR 26302, May 12, 2004]