§341.74. Labeling of antitussive drug products. — Inbound Citations

(a) 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 §§ 341.72(b) and 341.74(b). The warnings shall be combined from §§ 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 § 341.74(c) shall be used. The directions for OTC labeling shall follow §§ 341.74(d)(1)(iv) or (d)(1)(v), as applicable. The directions for professional labeling shall follow § 341.90(j) or (k), as applicable.

(5) The labeling for antitussive ingredients in § 341.74(b) should be used.

(a) 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 §§ 341.72(b) and 341.74(b). The warnings shall be combined from §§ 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 § 341.74(c) shall be used. The directions for OTC labeling shall follow §§ 341.74(d)(1)(iv) or (d)(1)(v), as applicable. The directions for professional labeling shall follow § 341.90(j) or (k), as applicable.

(5) The labeling states the warnings for topical antitussive ingredients in § 341.74(c).

(a) 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 §§ 341.72(b) and 341.74(b). The warnings shall be combined from §§ 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 § 341.74(c) shall be used. The directions for OTC labeling shall follow §§ 341.74(d)(1)(iv) or (d)(1)(v), as applicable. The directions for professional labeling shall follow § 341.90(j) or (k), as applicable.

(i) The following warning should be used instead of the warnings in § 341.74(c)(1) and part 343 of this chapter: “Stop use and ask a doctor if [in bold type] [bullet] pain or cough 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 [bullet] cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.”

(a) 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 §§ 341.72(b) and 341.74(b). The warnings shall be combined from §§ 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 § 341.74(c) shall be used. The directions for OTC labeling shall follow §§ 341.74(d)(1)(iv) or (d)(1)(v), as applicable. The directions for professional labeling shall follow § 341.90(j) or (k), as applicable.

(iii) The following warning should be used instead of the warnings in § 341.74(c)(2) and part 343 of this chapter: “Stop use and ask a doctor if [in bold type] [bullet] pain or cough 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 [bullet] cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.”

(a) 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 §§ 341.72(b) and 341.74(b). The warnings shall be combined from §§ 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 § 341.74(c) shall be used. The directions for OTC labeling shall follow §§ 341.74(d)(1)(iv) or (d)(1)(v), as applicable. The directions for professional labeling shall follow § 341.90(j) or (k), as applicable.

(ii) The following warning should be used instead of the warnings in § 341.74(c)(3) and part 343 of this chapter: “Stop use and ask a doctor if [in bold type] [bullet] pain or cough 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 [bullet] cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.”

(a) 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 §§ 341.72(b) and 341.74(b). The warnings shall be combined from §§ 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 § 341.74(c) shall be used. The directions for OTC labeling shall follow §§ 341.74(d)(1)(iv) or (d)(1)(v), as applicable. The directions for professional labeling shall follow § 341.90(j) or (k), as applicable.

(C) Flammability warning, with appropriate flammability signal word(s) (e.g., §§ 341.74(c)(5)(iii), 344.52(c), 358.150(c), and 358.550(c) of this chapter). This warning shall follow a subheading containing the appropriate flammability signal word(s) described in an applicable OTC drug monograph or approved drug application.

The active ingredients of the product consist of any of the following when used within the dosage limits and in the dosage forms established for each ingredient in § 341.74(d):

(2) The labeling states the directions for topical antitussive ingredients in § 341.74(d).

(a) 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 §§ 341.72(b) and 341.74(b). The warnings shall be combined from §§ 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 § 341.74(c) shall be used. The directions for OTC labeling shall follow §§ 341.74(d)(1)(iv) or (d)(1)(v), as applicable. The directions for professional labeling shall follow § 341.90(j) or (k), as applicable.

(a) 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 §§ 341.72(b) and 341.74(b). The warnings shall be combined from §§ 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 § 341.74(c) shall be used. The directions for OTC labeling shall follow §§ 341.74(d)(1)(iv) or (d)(1)(v), as applicable. The directions for professional labeling shall follow § 341.90(j) or (k), as applicable.

(f) The labeling for antitussive drug products containing the active ingredient identified in § 341.14(b)(2) marketed in accordance with § 341.74(d)(2)(iii) is exempt from the requirement in § 330.1(g) of this chapter that the labeling bear the general warning statement “In case of accidental overdose, seek professional assistance or contact a poison control center immediately.” The labeling must continue to bear the first part of the general warning in § 330.1(g) of this chapter, which states, “Keep this and all drugs out of the reach of children.”