Temazepam 7.5 MG Oral Capsule
INDICATIONS AND USAGE Temazepam capsules are 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 temazepam capsules 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.
Amneal Pharmaceuticals LLC
CAPSULE BLUE AMNEAL 583
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HOW SUPPLIED
TEMAZEPAM capsules, USP 7.5 mg are hard gelatin capsules with white opaque body printed radially “583” with black ink and blue opaque cap printed radially “AMNEAL” with black ink. They are available as follows: Bottles of 30: NDC 65162-583-03 Bottles of 100: NDC 65162-583-10 Bottles of 500: NDC 65162-583-50 Bottles of 1000: NDC 65162-583-11
TEMAZEPAM capsules, USP 15 mg are hard gelatin capsules with white opaque body printed radially “556” with black ink and blue green opaque cap printed radially “AMNEAL” with black ink. They are available as follows: Bottles of 30: NDC 65162-556-03 Bottles of 100: NDC 65162-556-10 Bottles of 500: NDC 65162-556-50 Bottles of 1000: NDC 65162-556-11
TEMAZEPAM capsules, USP 22.5 mg are hard gelatin capsules with white opaque body printed radially “584” with black ink and dark pink opaque cap printed radially “AMNEAL” with black ink. They are available as follows: Bottles of 30: NDC 65162-584-03 Bottles of 100: NDC 65162-584-10 Bottles of 500: NDC 65162-584-50 Bottles of 1000: NDC 65162-584-11
TEMAZEPAM capsules, USP 30 mg are hard gelatin capsules with white opaque body printed radially “557” with black ink and white opaque cap printed radially “AMNEAL” with black ink. They are available as follows: Bottles of 30: NDC 65162-557-03 Bottles of 100: NDC 65162-557-10 Bottles of 500: NDC 65162-557-50 Bottles of 1000: NDC 65162-557-11 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]. Manufactured by: Amneal Pharmaceuticals of NY LLC Brookhaven, NY 11719 Distributed by: Amneal Pharmaceuticals LLC Glasgow, KY 42141 Rev. 02-2023-05
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