Promethazine Hydrochloride And Dextomethorphan Hydrobromide Solution Recall
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Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
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Each 5 mL (one teaspoonful), for oral administration contains: dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%.
Inactive Ingredients: Ascorbic Acid, Citric Acid, Edetate Disodium, FD&C Yellow #6, Glycerin, Methylparaben, Natural & Artificial Flavors, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Citrate, and Sucrose.
Dextromethorphan hydrobromide 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. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NO•HBr•H20, and the following structural formula:
Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as "10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-, monohydrochloride".
Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2S •HCI, and the following structural formula: