Temazepam 30 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.

Actavis Pharma, Inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] pain` `[4] off label use` `[5] adverse drug reaction` `[6] alopecia` `[7] rash` `[8] headache` `[9] arthralgia` `[10] rheumatoid arthritis`

5 years ago

CAPSULE WHITE R 077

HOW SUPPLIED

TEMAZEPAM capsules, USP are available as follows: 15 mg — Each #3 capsule with green opaque cap and white opaque body, imprinted with 076 in black ink on both cap and body contains 15 mg of

TEMAZEPAM, USP. capsules are supplied in bottles of 100 (NDC 0228-2076-10) and 500 (NDC 0228-2076-50). 30 mg — Each #3 capsule with white opaque cap and body, imprinted with 077 in black ink on both cap and body contains 30 mg of

TEMAZEPAM, USP. capsules are supplied in bottles of 100 (NDC 0228-2077-10) and 500 (NDC 0228-2077-50). Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. D 2/2023 1 1

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Temazepam 30 MG Oral Capsule

FDA Reported Adverse Reactions [1] drug ineffective [2] fatigue [3] pain [4] off label use [5] adverse drug reaction [6] alopecia [7] rash [8] headache [9] arthralgia [10] rheumatoid arthritis

CAPSULE WHITE R 077

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FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] pain` `[4] off label use` `[5] adverse drug reaction` `[6] alopecia` `[7] rash` `[8] headache` `[9] arthralgia` `[10] rheumatoid arthritis`