SPL Set ID: 0fda7521-a452-4bac-953d-7d464d75ca22

Chlordiazepoxide hydrochloride and clidinium bromide capsules, USP are a fixed-combination of chlordiazepoxide hydrochloride, a benzodiazepine, and clidinium bromide, an anticholinergic. Each chlordiazepoxide hydrochloride and clidinium bromide capsule USP contains the active ingredients 5 mg chlordiazepoxide hydrochloride USP and 2.5 mg clidinium bromide USP. Each capsule also contains the inactive ingredients: corn starch, lactose monohydrate and talc. The capsule shell contains D&C yellow - 10, FD&C blue - 1, gelatin, sodium lauryl sulfate and titanium dioxide. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide and shellac. Chlordiazepoxide hydrochloride USP is 7-chloro-2-methylamino-5-phenyl-3H-1,4-benzodiazepine 4-oxide hydrochloride. A white to slightly yellow crystalline powder, it is freely soluble in water, sparingly soluble in ethanol and insoluble in hexane. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.22. The structural formula of chlordiazepoxide hydrochloride is as follows: Clidinium bromide USP is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have antispasmodic and antisecretory effects on the gastrointestinal tract. Structurally clidinium bromide is: Meets USP Dissolution Test 2. Chemical Structure1 Chemical Structure2