KETALAR (Page 4 of 4)

17 Patient Counseling Information

Studies conducted in young animals and children suggest repeated or prolonged use of general anesthetic or sedation drugs in children younger than 3 years may have negative effects on their developing brains. Discuss with parents and caregivers the benefits, risks, and timing and duration of surgery or procedures requiring anesthetic and sedation drugs [see Warnings and Precautions (5.5)].
Due to the residual anesthetic effects and the potential for drowsiness, advise patients not to drive an automobile, operate hazardous machinery, or engage in hazardous activities within 24 hours of receiving KETALAR.

Distributed by:

Par Pharmaceutical

Chestnut Ridge, NY 10977

R8/2020

OS115J-01-90-053000442K

Sample Package Label

//medlibrary.org/lib/images-rx/ketalar/label1-300x286.jpg
(click image for full-size original)

KETALAR ketamine hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52584-037(NDC:42023-113)
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETAMINE HYDROCHLORIDE (KETAMINE) KETAMINE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZETHONIUM CHLORIDE
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52584-037-10 1 VIAL in 1 BAG contains a VIAL
1 20 mL in 1 VIAL This package is contained within the BAG (52584-037-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016812 10/17/2012
Labeler — General Injectables & Vaccines, Inc (108250663)
Establishment
Name Address ID/FEI Operations
General Injectables & Vaccines, Inc 108250663 relabel (52584-037)

Revised: 07/2021 General Injectables & Vaccines, Inc

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