SPL Set ID: 8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc

Morphine Sulfate Oral Solution is an opioid agonist, available in the following concentrations for oral administration: 10 mg per 5 mL (2 mg/mL): Each 1 mL of oral solution contains 2 mg of morphine sulfate, USP (equivalent to 1.5 mg morphine). 20 mg per 5 mL (4 mg/mL): Each 1 mL of oral solution contains 4 mg of morphine sulfate, USP (equivalent to 3 mg morphine). 100 mg per 5 mL (20 mg/mL): Each 1 mL of oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine). The chemical name is 7,8-didehydro-4,5 alpha-epoxy-17 methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate. The molecular weight is 758.83. Its molecular formula is (C 17 H 21 NO 3 ) 2 ∙H 2 SO 4 ∙5H 2 O, and it has the following chemical structure. Morphine sulfate, USP is a white to off-white crystalline powder or a fine white to light yellow powder. It is soluble in water and slightly soluble in alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). For the 10 mg per 5 mL (2 mg/mL) concentration: Each 5 mL of oral solution contains 10 mg of morphine sulfate, USP and the following inactive ingredients: citric acid anhydrous, disodium edetate, FD&C Green No. 3 (fast green), glycerin, sodium benzoate, sorbitol and purified water. For the 20 mg per 5 mL (4 mg/mL) concentration: Each 5 mL of oral solution contains 20 mg of morphine sulfate, USP and the following inactive ingredients: citric acid anhydrous, disodium edetate, FD&C Green No. 3 (fast green), glycerin, methylparaben, propylparaben, sodium benzoate, sorbitol and purified water. For the 100 mg per 5 mL (20 mg/mL) concentration (only for opioid-tolerant adults) : Each 5 mL of oral solution contains 100 mg of morphine sulfate, USP and the following inactive ingredients: citric acid anhydrous, disodium edetate, glycerin, sodium benzoate, sorbitol and purified water. Additionally, the tinted solution contains D & C Red No. 33 and sucralose. Chemical Structure