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NDC 39822-5550-06

PROMETHAZINE HYDROCHLORIDE 50 mg/mL INJECTION, SOLUTION

XGen Pharmaceuticals DJB, Inc.

Available — 2-Day Shipping
NDC
39822-5550-06
Generic Name
PROMETHAZINE HYDROCHLORIDE
Brand Name
PROMETHAZINE HYDROCHLORIDE
Strength
50 mg/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAMUSCULAR, INTRAVENOUS
Package Size
Labeler
XGen Pharmaceuticals DJB, Inc.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Promethazine hydrochloride injection is indicated for the following conditions: Amelioration of allergic reactions to blood or plasma. In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled. For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. For sedation and relief of apprehension and to produce light sleep from which the patient can be easily ar…

Important Warnings

WARNINGS Respiratory Depression Pediatrics Promethazine hydrochloride injection should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Post-marketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients less than 2 years of age. A wide range of weight-based dose…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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