"The U.S. Food and Drug Administration today announced it required the manufacturer of the sleep drug Lunesta (eszopiclone) to change the drug label and lower the current recommended starting dose. Data show that eszopiclone levels in some patient"...
DOSAGE AND ADMINISTRATION
Dosage Forms And Strengths
Capsules: 20 mg size 1 dark blue opaque, hard gelatin capsules printed with “VANDA 20 mg” in white.
Storage And Handling
HETLIOZ 20 mg capsules are available as size 1, dark blue opaque, hard gelatin capsules printed with “VANDA 20 mg” in white, containing 20 mg of tasimelteon per capsule.
NDC 43068-220-01 Bottles of 30
Store HETLIOZ 20 mg capsules at controlled room temperature, 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect HETLIOZ 20 mg capsules from exposure to light and moisture.
Distributed by: Vanda Pharmaceuticals Inc. Washington, D.C. 20037 USA www.hetlioz.com. Revised: Dec 2014
Last reviewed on RxList: 12/29/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Hetlioz Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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