Temazepam 22.5 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.
Mylan Pharmaceuticals Inc.
CAPSULE YELLOW MYLAN 3120
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HOW SUPPLIED Temazepam capsules, USP are available containing 7.5 mg, 15 mg, 22.5 mg or 30 mg of temazepam, USP. The 7.5 mg capsules are hard-shell gelatin capsules with a peach opaque cap and an ivory opaque body filled with an off-white powder blend. The capsules are axially printed with MYLAN over 3110 in black ink on both the cap and the body. They are available as follows: NDC 0378-3110-01 bottles of 100 capsules The 15 mg capsules are hard-shell gelatin capsules with a peach opaque cap and a peach opaque body filled with an off-white powder blend. The capsules are axially printed with MYLAN over 4010 in black ink on both the cap and the body. They are available as follows: NDC 0378-4010-77 bottles of 90 capsules NDC 0378-4010-01 bottles of 100 capsules NDC 0378-4010-05 bottles of 500 capsules The 22.5 mg capsules are hard-shell gelatin capsules with a yellow opaque cap and a peach opaque body filled with an off-white powder blend. The capsules are axially printed with MYLAN over 3120 in black ink on both the cap and the body. They are available as follows: NDC 0378-3120-93 bottles of 30 capsules The 30 mg capsules are hard-shell gelatin capsules with a yellow opaque cap and a yellow opaque body filled with an off-white powder blend. The capsules are axially printed with MYLAN over 5050 in black ink on both the cap and the body. They are available as follows: NDC 0378-5050-77 bottles of 90 capsules NDC 0378-5050-01 bottles of 100 capsules NDC 0378-5050-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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