SPL Set ID: 702eb7c0-db4c-4729-b69e-99f64c63c7bd

Each 5 mL (teaspoon) of Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution contains 6.25 mg promethazine hydrochloride USP and 15 mg dextromethorphan hydrobromide USP in a flavored syrup base with a pH between 4.5 and 5.5. The inactive ingredients present are alcohol 7% (v/v), ascorbic acid, citric acid, black currant flavor, D&C Yellow 10, edetate disodium, FD&C Yellow 6, glycerin, L-Menthol, sodium benzoate, sodium citrate, sodium propionate, saccharin sodium, sucrose, and water. Promethazine hydrochloride USP is a racemic compound; the empirical formula is C 17 H 20 N 2 S•HCl and its molecular weight is 320.88. Promethazine hydrochloride USP, a phenothiazine derivative, is chemically designated as 10 H -Phenothiazine-10-ethanamine, N , N , α-trimethyl-, monohydrochloride, (+)- with the following structural formula: Promethazine hydrochloride USP occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol. Dextromethorphan hydrobromide USP is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α–morphinan hydrobromide monohydrate with the following structural formula: Dextromethorphan hydrobromide monohydrate occurs as white crystals, is sparingly soluble in water, and is freely soluble in alcohol. The empirical formula is C 18 H 25 NO•HBr•H 2 O, and the molecular weight of the monohydrate is 370.33. Dextromethorphan hydrobromide monohydrate is dextrorotatory with a specific rotation of +27.6 degrees in water (20 degrees C, sodium D-line). Prometh_structure.jpg Dextro_structure.jpg