Drug Information for DIAZEPAM ORAL SOLUTION, 5 mg per 5 mL and DIAZEPAM INTENSOL™ Oral Solution (Concentrate), 5 mg per mL (Roxane Laboratories, Inc.): DESCRIPTION

Each 5 mL of Oral Solution contains:

Diazepam........................................................... 5 mg

Each mL of Intensol^TM Oral Solution (Concentrate) contains:

Diazepam............................................................ 5 mg

Alcohol................................................................ 19%

Inactive Ingredients:

The wintergreen-spice flavored 5 mg/5 mL Oral Solution contains bitterness modifier, citric acid, D&C Yellow No. 10, FD&C Red No. 40, flavoring, polyethylene glycol, propylene glycol, sodium citrate, sorbitol, and water.

The 5 mg/mL Intensol^TM Oral Solution (Concentrate) contains alcohol, D&C Yellow No. 10, polyethylene glycol, propylene glycol, succinic acid, and water.

Diazepam is a benzodiazepine derivative. Chemically, diazepam is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline compound, insoluble in water and has a molecular weight of 284.74. Its structural formula is as follows: