Methyldopa injection labels and packages

Methyldopa
Methyldopa tablet® FDA Package Insert
Indications and Usage
Dosage and Administration
Contraindications
Warnings
Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
How Supplied/Storage and Handling
Labels and Packages
Methyldopa injection® FDA Package Insert
Indications and Usage
Dosage and Administration
Contraindications
Warnings
Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
How Supplied/Storage and Handling
Labels and Packages
Clinical Trials on Methyldopa
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Container

NDC 0517-8905-10

METHYLDOPATE HCl INJECTION, USP

250 mg/5 mL (50 mg/mL)

5 mL SINGLE DOSE VIAL

FOR IV USE AFTER DILUTION

Rx Only

AMERICAN REGENT, INC. SHIRLEY, NY 11967

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Carton

PRINCIPAL DISPLAY PANEL – Carton

METHYLDOPATE HCl INJECTION, USP

250 mg/5 mL (50 mg/mL)

NDC 0517-8905-10

10 x 5 mL SINGLE DOSE VIALS

FOR INTRAVENOUS USE AFTER DILUTION

Rx Only

Each mL contains: Methyldopate HCl 50 mg, Citric Acid (Anhydrous) 5 mg, Edetate Disodium 0.5 mg, Monothioglycerol 2 mg, Water for Injection q.s. Methylparaben 1.5 mg and Propylparaben 0.2 mg added as preservatives, Sodium Bisulfite 3.2 mg added as an antioxidant. pH adjusted with Sodium Hydroxide and/or Hydrochloric Acid. DISCARD UNUSED PORTION. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). Directions for Use: See Package Insert.

AMERICAN REGENT, INC. SHIRLEY, NY 11967

Rev. 11/05

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