HYDROMORPHONE HCL - hydromorphone 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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Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial

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• WARNINGS AND PRECAUTIONS

Outsourced Compounded Drug. Not for Resale. Hospital/Office Use Only.

• ADVERSE EVENTS

To facilitate Adverse Event Reporting: www.fda.gov/medwatch or 1-800-FDA-1088.

• HOW SUPPLIED

Contains 30 mL (30 mg) of Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride in a 30 mL Single Use PCA Vial.


This product is Sterile, Nonpyrogenic, Preservative Free, and Latex Free.

• INGREDIENTS

Each 1 mL contains Hydromorphone HCl 1 mg, Sodium Chloride 9 mg. May contain Hydrochloric Acid and/or Sodium Hydroxide for pH adjustment.

• STORAGE AND HANDLING

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from freezing. Protect from Light.

• DOSAGE AND ADMINISTRATION.

FOR SLOW INTRAVENOUS USE. PRESERVATIVE FREE INJECTION SOLUTION.

Rx Only

Rev. 01/15

CANTRELL DRUG COMPANY
LITTLE ROCK, AR 72207

HYDROMORPHONE HCL 
hydromorphone hcl injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:52533-006
Route of AdministrationINTRAVENOUSDEA ScheduleCII    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE) HYDROMORPHONE HYDROCHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Chloride9 mg  in 1 mL
WATER 
Other Ingredients
Ingredient KindIngredient NameQuantity
May containHYDROCHLORIC ACID 
May containSODIUM HYDROXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52533-006-0530 mL in 1 VIAL, PATENT DELIVERY SYSTEM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/30/2011
Labeler - Cantrell Drug Company (035545763)

Revised: 1/2015
Document Id: 6e84a7a9-7401-40da-8fdf-1436acfa260b
Set id: 467c62b6-8ec1-4b72-8987-c32b8a3400a6
Version: 15
Effective Time: 20150119
 
Cantrell Drug Company