[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: 21CFR341.70]

[Page 241]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 341_COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS 
 
                           Subpart C_Labeling
 
Sec.  341.70  Labeling of OTC drug products containing ingredients that are 


used for treating concurrent symptoms (in either a single-ingredient or 

combination drug product).

    The statements of identity, indications, warnings, and directions 
for use, respectively, applicable to each ingredient in the product may 
be combined to eliminate duplicative words or phrases so that the 
resulting information is clear and understandable.
    (a) For products containing diphenhydramine citrate and 
diphenhydramine hydrochloride identified in Sec.  341.14(a)(5) and 
(a)(6). The labeling of the product contains the established name of the 
drug, if any, and identifies the product as an ``antihistamine/cough 
suppressant'' or ``antihistamine/antitussive (cough suppressant).'' The 
indications shall be combined from Sec. Sec.  341.72(b) and 341.74(b). 
The warnings shall be combined from Sec. Sec.  341.72(c)(1), (c)(2), 
(c)(4), and (c)(6) and 341.74(c)(1), (c)(2), (c)(3), and (c)(4). 
Alternatively, all of the warnings in Sec.  341.74(c) shall be used. The 
directions for OTC labeling shall follow Sec. Sec.  341.74(d)(1)(iv) or 
(d)(1)(v), as applicable. The directions for professional labeling shall 
follow Sec.  341.90(j) or (k), as applicable.
    (b) For products containing menthol identified in Sec. Sec.  
341.14(b)(2) and 356.12(f) of this chapter. The product contains 5 to 10 
milligrams menthol. The labeling of the product contains the established 
name of the drug, if any, and identifies the product as a ``cough 
suppressant/oral anesthetic'' or ``antitussive (cough suppressant)/oral 
anesthetic.'' The indications shall be combined from Sec.  341.74(b) and 
part 356 of this chapter. The warnings shall be combined from Sec.  
341.74(c)(1), (c)(2), and (c)(3) and part 356 of this chapter. The 
directions shall be: ``Directions [in bold type] [bullet]\1\ adults and 
children 2 years and over: dissolve lozenge slowly in the mouth. Repeat 
every 2 hours as needed or as directed by a doctor. [bullet] children 
under 2 years of age: ask a doctor''.
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    \1\See Sec.  201.66(b)(4) of this chapter for definition of bullet 
symbol.

[61 FR 15703, Apr. 9, 1996, as amended at 67 FR 78170, Dec. 23, 2002; 68 
FR 17881, Apr. 14, 2003]