SPL Set ID: a4370eb4-b00d-4247-af8d-980e59fbbec6

1 drug(s) with this SPL Set ID

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Temazepam TEMAZEPAM
ACTAVIS PHARMA, INC. FDA Rx Only

Temazepam, USP is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and the structural formula is: Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol, USP. Temazepam capsules USP, 15 mg and 30 mg, are for oral administration. Active Ingredient: temazepam, USP Inactive Ingredients: colloidal silicon dioxide, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide and may contain sodium lauryl sulfate. In addition, the 15 mg capsule also contains: D&C yellow #10, FD&C green #3, FD&C yellow #6 (Sunset Yellow). The imprinting ink, common for both strengths, contains: black iron oxide, D&C yellow #10 aluminum lake, FD&C blue#1 brilliant blue FCF aluminum lake, FD&C blue #2 indigo carmine aluminum lake, FD&C red #40 allura red AC aluminum lake, propylene glycol, and shellac. 1

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