Restoril®
(temazepam)
capsules USP
Rx only
DESCRIPTION
Restoril® (temazepam) 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 is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol, USP.
Restoril® (temazepam) capsules, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration.
7.5 mg, 15 mg, 22.5 mg, and 30 mg Capsules
Active Ingredient: temazepam, USP
7.5 mg Capsules
Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide.
May also include: n-butyl alcohol, iron oxide red, shellac, shellac glaze, SD-35A alcohol.
15 mg Capsules
Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide.
May also include: n-butyl alcohol, FD&C Blue #1 / Brilliant Blue FCF Aluminum Lake, iron oxide red, isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol.
22.5 mg Capsules
Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide.
May also include: n-butyl alcohol, FD&C Blue #1 / Brilliant Blue FCF Aluminum Lake, iron oxide red, isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol.
30 mg Capsules
Inactive Ingredients: FD&C Blue #1, FD&C Red #3, gelatin, lactose, magnesium stearate, red iron oxide, titanium dioxide.
May also include: n-butyl alcohol, FD&C Blue #1 / Brilliant Blue FCF Aluminum Lake, iron oxide red, isopropyl alcohol, propylene glycol, shellac, shellac glaze, SD-35A alcohol, SD-45 alcohol.
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