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''.---------------------------------------------------------------------------
\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]