21 C.F.R. § 341.16
Bronchodilator active ingredients.
Cite as 21 C.F.R. § 341.16 (2026)
The active ingredients of the product consist of any of the following when used within the dosage limits established for each ingredient:
(a) Ephedrine.
(b) Ephedrine hydrochloride.
(c) Ephedrine sulfate.
(d) Epinephrine.
(e) Epinephrine bitartrate.
(f) Racephedrine hydrochloride.
(g) Racepinephrine hydrochloride.
[51 FR 35339, Oct. 2, 1986]