[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR341.70]

[Page 233]
 
                        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]

    Effective Date Note: At 67 FR 78170, Dec. 23, 2002, Sec. 341.70 was 
amended by adding paragraph (b), effective Dec. 23, 2004. For the 
convenience of the user, the added text is set forth as follows:

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).

                                * * * * *

    (b) For products containing menthol identified in Secs. 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 hour 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.

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