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:

Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Logo

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 Label
(click image for full-size original)

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

PRINCIPAL DISPLAY PANEL -- 50 mL Vial Tray
(click image for full-size original)
MANNITOL
mannitol injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-4031
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MANNITOL (MANNITOL) MANNITOL 12.5 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER
SODIUM BICARBONATE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-4031-01 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0409-4031-16)
1 NDC:0409-4031-16 50 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0409-4031-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA016269 11/30/2004
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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