[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.315]
[Page 84]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 201 LABELING--Table of Contents
Subpart G Specific Labeling Requirements for Specific Drug Products
Sec. 201.315 Over-the-counter drugs for minor sore throats; suggested
warning.
The Food and Drug Administration has studied the problem of the
labeling of lozenges or troches containing a local anesthetic, chewing
gum containing aspirin, various mouth washes and gargles and other
articles sold over the counter for the relief of minor irritations of
the mouth or throat. It will not object to the labeling of suitable
articles of this type ``For the temporary relief of minor sore
throats'', provided this is immediately followed in the labeling with a
warning statement in prominent type essentially as follows: ``Warning--
Severe or persistent sore throat or sore throat accompanied by high
fever, headache, nausea, and vomiting may be serious. Consult physician
promptly. Do not use more than 2 days or administer to children under 3
years of age unless directed by physician.''
Back to Top
© 2007 Betterchem Corp.
|
