Source: FDA, National Drug Code (US) Revision Year: 2021
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 USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for oral administration.
Active Ingredient: temazepam USP
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.
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.
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.
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.
| How Supplied |
|---|
7.5.137 Restoril (temazepam) Capsules USP7.5 mg: Blue and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and Bottle of 30 NDC 0406-9915-03 15 mg: Maroon and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and Bottle of 100 NDC 0406-9916-01 22.5 mg: Opaque blue capsules, with the opaque blue body imprinted “FOR SLEEP” on one side and Bottle of 30 NDC 0406-9914-03 30 mg: Maroon and blue capsules, with the blue body imprinted “FOR SLEEP” on one side and Bottle of 100 NDC 0406-9917-01 Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, |
| Drug | Countries | |
|---|---|---|
| RESTORIL | Canada, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
on the other side in red, and a blue cap imprinted “RESTORIL 7.5 mg” twice in red.