StacksVerified U.S. regulatory reference

21 CFR §346.12

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
The active ingredient of the product consists of any of the following when used in the concentration or within the concentration range established for each ingredient.
  1. (a)Ephedrine sulfate 0.1 to 1.25 percent.
  2. (b)Epinephrine 0.005 to 0.01 percent.
  3. (c)Epinephrine hydrochloride 0.005 to 0.01 percent.
  4. (d)Phenylephrine hydrochloride 0.25 percent.