SPL Set ID: 88ed4ccf-9e35-4142-a5eb-d2b5edd36956

Each 5 mL of oral solution contains: 2.5 mg of diphenoxylate hydrochloride USP (equivalent to 2.3 mg of diphenoxylate), 0.025 mg of atropine sulfate USP (equivalent to 0.01 mg of atropine), and 15% alcohol. Diphenoxylate hydrochloride, an antidiarrheal, is ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisoni-pecotate monohydrochloride and has the following structural formula: C 30 H 32 N 2 O 2 · HCl M.W. 489.05 Atropine sulfate, an anticholinergic, is endo-(±)-α-(hydroxymethyl) benzeneacetic acid 8-methyl-8-azabicyclo[3.2.1] oct-3-yl ester sulfate (2:1) (salt) monohydrate and has the following structural formula: (C 17 H 23 NO 3 ) 2 · H 2 SO 4 · H 2 O M.W. 694.83 A subtherapeutic amount of atropine sulfate is present to discourage deliberate overdosage. Inactive ingredients of diphenoxylate hydrochloride and atropine sulfate oral solution, USP include alcohol, anhydrous citric acid, FD&C Red No. 40, FD&C Yellow No. 6, glycerin, maltol, potassium sorbate, purified water, sorbitol solution and wild cherry flavor. chem-1.jpg chem-2.jpg