§341.80. Labeling of nasal decongestant drug products. — Inbound Citations

(3) The title, heading, subheadings, and information in paragraphs (c)(1) through (c)(9) of this section shall be legible and clearly presented, shall have at least 0.5-point leading (i.e., space between two lines of text), and shall not have letters that touch. The type style for the title, headings, subheadings, and all other required information described in paragraphs (c)(2) through (c)(9) of this section shall be any single, clear, easy-to-read type style, with no more than 39 characters per inch. The title and headings shall be in bold italic, and the subheadings shall be in bold type, except that the word “(continued)” in the title “Drug Facts (continued)” shall be regular type. The type shall be all black or one color printed on a white or other contrasting background, except that the title and the headings may be presented in a single, alternative, contrasting color unless otherwise provided in an approved drug application, OTC drug monograph (e.g., current requirements for bold print in §§ 341.76 and 341.80 of this chapter), or other OTC drug regulation (e.g., the requirement for a box and red letters in § 201.308(c)(1)).

(6) The labeling for nasal decongestant ingredients in § 341.80(b) should be used.

(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.

(i) The following warning should be used instead of the warnings in § 341.80(c)(1)(i)(B) and part 343 of this chapter: “Stop use and ask a doctor if [in bold type] [bullet] pain or nasal congestion gets worse or lasts more than 7 days [bullet] fever gets worse or lasts more than 3 days [bullet] redness or swelling is present [bullet] new symptoms occur”.

(ii) The following warning should be used instead of the warnings in § 341.80(c)(1)(ii)(B) and part 343 of this chapter: “Stop use and ask a doctor if [in bold type] [bullet] pain or nasal congestion gets worse or lasts more than 5 days [bullet] fever gets worse or lasts more than 3 days [bullet] redness or swelling is present [bullet] new symptoms occur”.

(iii) The following warning should be used instead of the warnings in § 341.80(c)(1)(iii) and part 343 of this chapter: “Stop use and ask a doctor if [in bold type] [bullet] pain or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) [bullet] fever gets worse or lasts more than 3 days [bullet] redness or swelling is present [bullet] new symptoms occur”.

(6) The labeling states the warnings for topical nasal decongestant ingredients in § 341.80(c)(2).

(3) The labeling states the directions for topical nasal decongestant ingredients in § 341.80(d)(2)(i) and (d)(2)(viii).

(3) The labeling states the directions for topical nasal decongestant ingredients in § 341.80(d)(2)(i) and (d)(2)(viii).