21 C.F.R. § 335.10
Antidiarrheal active ingredients
The active ingredient of the product consists of any one of the following when used within the dosage limits established for each ingredient in § 335.50(d):
(a) Bismuth subsalicylate.
(b) Kaolin.
The active ingredient of the product consists of any one of the following when used within the dosage limits established for each ingredient in § 335.50(d):
(a) Bismuth subsalicylate.
(b) Kaolin.