Temazepam 15 MG Oral Capsule Restoril

INDICATIONS AND USAGE Restoril ™ (temazepam) is indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Restoril ™ (temazepam) should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.

SpecGx LLC

FDA Reported Adverse Reactions
`[1] fatigue` `[2] drug ineffective` `[3] pain` `[4] off label use` `[5] nausea` `[6] headache` `[7] pyrexia` `[8] dyspnoea` `[9] diarrhoea` `[10] arthralgia`

4 years ago

CAPSULE PINK 15 mg M FOR SLEEP

HOW SUPPLIED Restoril™ (

TEMAZEPAM) capsules USP 7.5 mg blue and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and ® on the other side in red, and a blue cap imprinted “RESTORIL 7.5 mg” twice in red. Bottle of 30 . . . . . . . . . .NDC 0406-9915-03 Bottle of 100 . . . . . . . . .NDC 0406-9915-01 Boxed M 15 mg maroon and pink capsules, with the pink body imprinted “FOR SLEEP” on one side and ® on the other side in red, and a maroon cap imprinted “RESTORIL 15 mg” twice in white. Bottle of 100 . . . . . . . . .NDC 0406-9916-01 Boxed M 22.5 mg Opaque blue capsules, with the opaque blue body imprinted “FOR SLEEP” on one side and ® on the other side in red, and an opaque blue cap imprinted “RESTORIL 22.5 mg” twice in red. Bottle of 30 . . . . . . . . . .NDC 0406-9914-03 Boxed M 30 mg maroon and blue capsules, with the blue body imprinted “FOR SLEEP” on one side and ® on the other side in red, and a maroon cap imprinted “RESTORIL 30 mg” twice in white. Bottle of 100 . . . . . . . . .NDC 0406-9917-01 Dispense in a well-closed, light-resistant container with a child-resistant closure. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo, and other brands are trademarks of a Mallinckrodt company. © 2023 Mallinckrodt. Rev 01/2023 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/L20R02.pdf or by calling 1-800-778-7898 for alternate delivery options. Boxed M Boxed M

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