Terbutaline Sulfate: Package Insert and Label Information (Page 2 of 2)

DOSAGE & ADMINISTRATION

Terbutaline Sulfate Injection, USP should be used only for subcutaneous administration and not intravenous infusion. Sterility and accurate dosing cannot be assured if the vials are not used in accordance with DOSAGE AND ADMINISTRATION.
Discard unused portion after single patient use.
The usual subcutaneous dose of Terbutaline Sulfate Injection, USP is 0.25 mg injected into the lateral deltoid area. If significant clinical improvement does not occur within 15 to 30 minutes, a second dose of 0.25 mg may be administered. If the patient then fails to respond within another 15 to 30 minutes, other therapeutic measures should be considered. The total dose within 4 hours should not exceed 0.5 mg.Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

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Discard unused portion after single patient use.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light. Do not use if solution is discolored.
Vial stoppers do not contain natural rubber latex.
APP
APP Pharmaceuticals, LLC
Schaumburg, IL 60173
451001DRevised: February 2011

Sample Package Label

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TERBUTALINE SULFATE terbutaline sulfate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-9962(NDC:63323-665)
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Terbutaline Sulfate (Terbutaline) Terbutaline Sulfate 1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0404-9962-01 1 VIAL in 1 BAG contains a VIAL
1 1 mL in 1 VIAL This package is contained within the BAG (0404-9962-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076887 01/12/2022
Labeler — Henry Schein, Inc. (012430880)

Revised: 01/2022 Henry Schein, Inc.

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