FDA Label for Dexmedetomidine Hydrochloride
View Indications, Usage & Precautions
Dexmedetomidine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Grindeks Joint Stock Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Warnings And Precautions
Caution: For manufacturing, processing, or repackaging, per 21 CFR 201.122.
Storage And Handling
Storage: Hygroscopic. Should be stored in a airtight container. Recommended storage temperature is from 15° to 30°C (59° to 86°F).
Package Label.Principal Display Panel
NDC Number: 64189-8502-1 Country of Origin: Latvia
DEXMEDETOMIDINE HYDROCHLORIDE
(Non-sterile, For Veterinary Use Only)
Cas Number: 145108-58-3
Lot Number:_______________ Release Date:____________
Net Weight:____________gram Retest Date:_____________ (Month, Year)
Storage: Hygroscopic. Should be stored in a airtight container. Recommended storage temperature is from 15° to 30°C (59° to 86°F).
Caution: For manufacturing, processing, or repackaging, per 21 CFR 201.122.
Grindex
Manufactured by: JSC GRINDEKS
53 Krustpils Street, Riga, LV-1057, Latvia
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