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NDC 67877-0148-01

temazepam 7.5 mg/1 CAPSULE

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NDC
67877-0148-01
Generic Name
temazepam
Brand Name
temazepam
Strength
7.5 mg/1
Dosage Form
CAPSULE
Route
ORAL
Package Size
Labeler
Ascend Laboratories, LLC

FDA Drug Information

Indications & Usage

INDICATIONS & USAGE Temazepam Capsules, USP 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.

Important Warnings

WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including Temazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use o…

Source: FDA. For professional use only. Not a substitute for prescribing information.

Other temazepam NDC Codes

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