Sonata 10 MG Oral Capsule

INDICATIONS AND USAGE Sonata is indicated for the short-term treatment of insomnia. Sonata has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY ). It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.

Physicians Total Care, Inc.

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

3 years ago

CAPSULE GREEN 10 mg SONATA

HOW SUPPLIED HOW SUPPLIED Sonata (zaleplon) capsules are supplied as follows: 5 mg: opaque green cap and opaque pale green body with “5 mg” on the cap and “SONATA” on the body. NDC 54868-5139-0 NDC 54868-5139-1 Bottles of 10 Bottles of 30 10 mg: opaque green cap and opaque light green body with “10 mg” on the cap and “SONATA” on the body. NDC 54868-4431-1 NDC 54868-4431-0 NDC 54868-4431-3 NDC 54868-4431-2 Bottles of 10 Bottles of 30 Bottles of 50 Bottles of 100 Sonata ® is a registered trademark of Jones Pharma Inc. ™ , a wholly owned subsidiary of King Pharmaceuticals ® , Inc. STORAGE CONDITIONS Store at controlled room temperature, 20°C to 25°C (68°F to 77°F). Dispense in a light-resistant container as defined in the USP. Repackaging and Relabeling by: Physicians Total Care, Inc. Tulsa, OK 74146

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Sonata 10 MG Oral Capsule

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

CAPSULE GREEN 10 mg SONATA

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