§341.90. Professional labeling. — 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.

(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.