21 C.F.R. 21 CFR--PART 341
Title 21 - Food and Drugs
Effective Date(s): April 11, 2007 5. Section 341.85 is amended by revising the headings in paragraphs (b)(2) and (b)(3) and by revising paragraph (b)(2)(ii) to read as follows: * * * * * (b)(2) For permitted combinations containing an analgesic-antipyretic active ingredient identified in §341.40(a), (c), (f), (g), (m), (q), and (r) when labeled for relief of hay fever/allergic rhinitis and/or nasal congestion symptoms. * * * * * (ii) The indication(s) for the cough-cold ingredient(s) consists of the labeling for antihistamines in §341.72(b)(1) or (b)(2) and/or nasal decongestants in §341.80(b)(1)(ii), as appropriate, and the labeling for any other cough-cold combination. This labeling may follow a separate bullet(s) or may be combined with the indication in paragraph (b)(2)(i) of this section. (b)(3) For permitted combinations containing an oral analgesic-antipyretic active ingredient identified in §341.40(a), (c), (f), (g), (m), (q), and (r) when labeled for relief of general cough-cold symptoms and/or the common cold and for relief of hay fever/allergic rhinitis and/or nasal congestion symptoms. * * * * *
Amendment from October 11, 2005
21 CFR--PART 341
Amendment(s) published October 11, 2005, in 70 FR 58977
§ 341.85 Labeling of permitted combinations of active ingredients.
