21 C.F.R. 21 CFR--PART 341
Title 21 - Food and Drugs
Effective Date(s): August 31, 2006 4. Section 341.80 is amended by revising the headings in paragraphs (c)(1)(i) and (c)(1)(ii), and by adding paragraph (d)(1)(iii) to read as follows: * * * * * (c) * * * (1) Oral nasal decongestants—(i) For products containing phenylephrine hydrochloride, pseudoephedrine hydrochloride, pseudoephedrine sulfate, or phenylephrine bitartrate identified in §341.20 (a)(1) through (a)(4) when labeled for adults. * * * * * * * * (ii) For products containing phenylephrine hydrochloride, pseudoephedrine hydrochloride, pseudoephedrine sulfate, or phenylephrine bitartrate identified in §341.20 (a)(1) through (a)(4) when labeled for children under 12 years of age. * * * * * * * * (d) * * * (1) * * * (iii) For products containing phenylephrine bitartrate identified in §341.20(a)(4). Include information on the number of dosage units and the quantity of water the dosage units are to be dissolved in prior to administration as shown in the following table: * * * * *
Amendment from August 01, 2006
21 CFR--PART 341
Amendment(s) published August 1, 2006, in 71 FR 43362
§ 341.80 Labeling of nasal decongestant drug products.
------------------------------------------------------------------------ Age\1\ Dose\1\------------------------------------------------------------------------Adults and children 12 years 15.6 milligrams every 4 hours not to of age and over exceed 62.4 milligrams in 24 hours------------------------------------------------------------------------Children 6 to under 12 years 7.8 milligrams every 4 hours not to of age exceed 31.2 milligrams in 24 hours------------------------------------------------------------------------Children under 6 years of age Ask a doctor------------------------------------------------------------------------\1\Headings are not required to appear in the product's labeling
