LABETALOL HCL  - labetalol hydrochloride injection, solution 
Cantrell Drug Company

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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LABETALOL HCL  labetalol injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52533-034 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE 5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength Anhydrous Dextrose 45 mg  in 1 mL Edetate Disodium 0.1 mg  in 1 mL Methylparaben 0.8 mg  in 1 mL Propylparaben 0.1 mg  in 1 mL Citric Acid Monohydrate   Sodium Hydroxide

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:52533-034-16 2 mL in 1 SYRINGE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/18/2012

Labeler - Cantrell Drug Company (035545763)

Revised: 08/2012 Cantrell Drug Company