SPL Set ID: 5f23b254-872b-4e88-91be-710c3ea7687b

1 drug(s) with this SPL Set ID

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Promethazine and Phenylephrine HCl, and Codeine Phosphate PROMETHAZINE PHENYLEPHRINE CODEINE

Promethazine and phenylephrine HCl and codeine phosphate oral solution, USP contains codeine USP, an opioid agonist; promethazine, a phenothiazine; and phenylephrine, an alpha-1 adrenergic receptor agonist. Each 5 mL of promethazine and phenylephrine HCl and codeine phosphate oral solution, USP contains 10 mg of codeine phosphate, USP, 6.25 mg of promethazine hydrochloride, USP and 5 mg of phenylephrine hydrochloride, USP for oral administration. Promethazine and phenylephrine HCl and codeine phosphate oral solution, USP contains Alcohol 7.15% v/v. Promethazine and phenylephrine HCl and codeine phosphate oral solution, USP also contains the following inactive ingredients: anhydrous citric acid, ascorbic acid, edetate disodium, glycerin, methylparaben, natural & artificial citrus flavor FN-7176, purified water, saccharin sodium, sodium benzoate, sodium metabisulfite, sodium citrate, and sucrose. Codeine Phosphate, USP The chemical name for codeine phosphate, USP is 7,8-Didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Codeine, USP is one of the naturally occurring phenanthrene alkaloids of opium derived from the opium poppy, it is classified pharmacologically as a narcotic analgesic. The phosphate salt of codeine, USP occurs as white, needle-shaped crystals or white crystalline powder. Codeine phosphate, USP is freely soluble in water and slightly soluble in alcohol. The molecular weight is 406.37. Its molecular formula is C 18 H 21 NO 3 •H 3 PO 4 • 1/2 H 2 O, and it has the following chemical structure. Promethazine Hydrochloride, USP The chemical name for promethazine hydrochloride USP, a phenothiazine derivative, is (±)-10-[2-(Dimethylamino)propyl] phenothiazine monohydrochloride. 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 soluble in water and freely soluble in alcohol. The molecular weight is 320.88. Its molecular formula is C 17 H 20 N 2 S • HCl, and it has the following chemical structure. Phenylephrine Hydrochloride, USP The chemical name for phenylephrine hydrochloride USP, a sympathomimetic amine salt, is (-)- m -hydroxy-α-[(methyl-amino)methyl] benzyl alcohol hydrochloride. Phenylephrine hydrochloride, USP occurs as white or nearly white crystals, having a bitter taste. It is freely soluble in water and alcohol. Phenylephrine hydrochloride, USP is subject to oxidation and must be protected from light and air. The molecular weight is 203.67. Its molecular formula is C 9 H 13 NO 2 • HCl, and it has the following chemical structure. 10 11 12

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