[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR341.70]

[Page 237]
 
                        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 FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                           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 Secs. 341.72(b) and 341.74(b). The 
warnings shall be combined from Secs. 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 Secs. 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) (Reserved)

[61 FR 15703, Apr. 9, 1996]