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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