Mannitol (Page 4 of 4)
16 HOW SUPPLIED/STORAGE AND HANDLING
Mannitol Injection 25%, USP is available as 12.5 g/50 mL (0.25 g/mL) of mannitol in a single-dose vial. Supplied as a tray of 25 vials (NDC 0409-4031-01).
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.
17 PATIENT COUNSELING INFORMATION
Inform patients or caregivers of the following risks of Mannitol Injection:
- Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
- Renal Complications Including Renal Failure [see Warnings and Precautions (5.2)].
- CNS Toxicity [see Warnings and Precautions (5.3)]
- Fluid and Electrolyte Imbalances, Hyperosmolarity [see Warnings and Precautions (5.4)]
- Infusion Site Reactions [see Warnings and Precautions (5.6)]
Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
LAB-1227-2.0
PRINCIPAL DISPLAY PANEL — 50 mL Vial Label
50 mL Single-dose Fliptop Vial
25% MANNITOL
Injection, USP
12.5 g/50 mL (250 mg/mL)
For Intravenous Use Only.
WARNING: SEE INSERT REGARDING
CONTRAINDICATION IN SEVERE
RENAL IMPAIRMENT.
Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
PRINCIPAL DISPLAY PANEL — 50 mL Vial Tray
50 mL Single-dose Fliptop Vial
25% MANNITOL
Injection, USP
12.5 g/50 mL
(250 mg/mL)
Rx only
NDC 0409-4031-01
Contains 25 of NDC 0409-4031-16
FOR INTRAVENOUS USE ONLY
Hospira
MANNITOL mannitol injection, solution | |||||||||||||||||
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Labeler — Hospira, Inc. (141588017) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Hospira, Inc. | 093132819 | ANALYSIS (0409-4031), MANUFACTURE (0409-4031), PACK (0409-4031), LABEL (0409-4031) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Hospira, Inc. | 827731089 | ANALYSIS (0409-4031) |
Revised: 12/2020 Hospira, Inc.
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