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 5 mg/mL 4 mL Syringe

Label

Label

LABETALOL HCL 
labetalol hcl injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:52533-034
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LABETALOL HYDROCHLORIDE (LABETALOL) LABETALOL HYDROCHLORIDE5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Anhydrous Dextrose45 mg  in 1 mL
Edetate Disodium0.1 mg  in 1 mL
Methylparaben0.8 mg  in 1 mL
Propylparaben0.1 mg  in 1 mL
Citric Acid Monohydrate 
Sodium Hydroxide 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52533-034-204 mL in 1 SYRINGE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/23/2012
Labeler - Cantrell Drug Company (035545763)

Revised: 10/2013
Document Id: aa8346c1-8fc8-4361-8465-425e5ddecdfd
Set id: f0a9df5b-45b5-4be5-aeb6-76d0c27a7799
Version: 3
Effective Time: 20131011
 
Cantrell Drug Company