DEXTROSE- dextrose monohydrate injection, solution

Dextrose by

Drug Labeling and Warnings

Dextrose by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Company, Baxter Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Health Care Professional Letter

Reporting Adverse Events or Product Quality Issues

To report adverse events associated with these imported products, please call Baxter at 1-866-888-2472, or fax: 1-800-759-1801. Adverse events or quality problems experienced with the use of these imported products may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, or by regular mail or by fax:

• Complete and submit the report Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
• Regular mail or Fax: Download form https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178).

To report product quality issues associated with these imported products, please contact Baxter Product Surveilance through Baxter Product Feedback Portal https://productfeedback.baxter.com/

Please refer to the FDA-approved prescribing information for each drug product listed below:

• Sterile Water for Injection USP (click https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018632s051lbl.pdf)
• 70% Dextrose Injection USP (click https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020047s021lbl.pdf)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Container Label

JB0297 3000 mL DIN 02014874
70% Dextrose Injection USP
Dextrose à 70% USP, Injectable

DEXTROSE 70%

2D Barcode
(01)00809080000654

Pharmacy Use Only / Dilute
Before Infusing
Pour Usage Par La Pharma-
cie Seulement / Diluer Avant
La Perfusion
Not for Direct Infusion /
Ne pa utilier pour perfuser directement

HYPERTONIC / HYPERTONIQUE

CONTAINS NO MORE THAN 25 µg/l OF ALUMINUM /
NE CONTENT PAS PLUS DE 25 µg/l D’ALUMINIUM

APPROX mOsmol/L – 3530 APPROX pH 4.0

INTRAVENOUS FLUID AND NUTRIENT REPLENISHMENT /
RECHARGE LIQUIDIENNE ET NUTRIMENT PAR
INJECTION INTRAVEINEUSE

PER 100 mL DEXTROSE HYDROUS USP – 70 g / WATER
FOR INJECTION USP qs
PAR 100 mL DEXTROSE HYDRATE USP – 70 g / EAU
POUR INJETION USP qs

COLOUR VARIATION FROM LIGHT YELLOW TO AMBER IS
NORMAL AND DOES NOT ALTER EFFICACY / IL EST NOR-
MAL QUE LA COULEUR VARIE D’UN JAUNE PALE A UN
JAUNE AMBRE ET CELA N’AFFECTE PAS L’EFFICACITE

AFFIX ACCOMPANYING LABEL FOR DATE AND TIME OF
ENTRY / APPOSER UNE ETIQUETTE ET INSCRIRE LA
DATE ET L’HEURE DU PRELEVEMENT INITIAL / DISCARD
UNUSED CONTENTS WITHIN 4 HOURS OF INITIAL ENTRY
/ JETER LE CONTENANT 4 HEURES APRES LE PREMIER
PRELEVEMENT

CAUTIONS SQUEEZE AND INSPECT BAG / SEE DIREC-
TIONS FOR USE / STORE AT 15°C TO 25°C
ATTENTIONS PRESSER ET INSPECTER LE SAC / VOIR
MODE D’EMPLOI / GARDER ENTIRE 15°C ET 25°C

NONPYROGENIC / STERILE / APYROGENE / STERILE
PRESCRIBING INFORMATION AVAILABLE ON REQUEST / INFORMA-
TION POSOLOGIQUE DISPONIBLE SUR DEMANDE

VIAFLEX PVC CONTAINER/CONTENANT DE PVC

BAXTER AND VIAFLEX ARE TRADEMARKS OF BAXTER INTERNATIONAL INC
BAXTER ET VIAFLEX SONT DE MARQUES DE COMMERCE DE BAXTER
INTERNATIONAL INC

Baxter Logo
BAXTER CORPORATION
Mississauga ON L5N 0C2

70%

No Latex Label
88-70-20-462

2100

1800

1500

1200

900

600

300

JB-02-97
4 – 3000 mL units
Store at 15°C to 25°C

70% Dextrose Injection USP

Lot:WWWWWWWWW EXP: 2099 99

2D Barcode
(01)20809080000658

Pharmacy Bulk

INGREDIENTS AND APPEARANCE

DEXTROSE 
dextrose monohydrate injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0338-9789
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	70 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0338-9789-04	4 in 1 CARTON	10/18/2024
1	NDC: 0338-9789-01	3000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		10/18/2024

Labeler - Baxter Healthcare Company (005083209)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Corporation		205087968	ANALYSIS(0338-9789) , LABEL(0338-9789) , MANUFACTURE(0338-9789) , STERILIZE(0338-9789) , PACK(0338-9789)