Magnesium Sulfate (Page 4 of 4)

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Magnesium Sulfate in 5% Dextrose Injection have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

16 HOW SUPPLIED/STORAGE AND HANDLING

Magnesium Sulfate in 5% Dextrose Injection, USP is supplied in a single-dose, single port bag with an aluminum overwrap. The infusion bags and ports are not made with natural rubber latex.

NDC Number Packaging Configuration Container Size Total Magnesium Sulfate * Total Magnesium Ion Magnesium Sulfate * Concentration Magnesium Ion Concentration Osmolarity
*
As the heptahydrate;
Osmolarity was calculated.

44567-410-24

24 bags per carton

100 mL

1 gram

8.1 mEq

0.01 grams/mL (1%)

8.1 mEq/100 mL

333 mOsmol/

liter

Storage

WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.
Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]
PROTECT FROM FREEZING

17 PATIENT COUNSELING INFORMATION

Magnesium Sulfate in 5% Dextrose Injection is typically administered to pregnancy women in emergent situations. When feasible, advise the patient and family of the following:

Fetal-Neonatal Toxicity Reported With Prolonged Use

Continuous administration of Magnesium Sulfate in 5% Dextrose Injection in pregnant women beyond 5 to 7 days can lead to hypocalcemia and bone abnormalities in the developing fetus, including skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported [see Warnings and Precautions (5.1)].

Risk of Magnesium Toxicity

Pregnant women receiving Magnesium Sulfate in 5% Dextrose Injection are at risk for magnesium toxicity, including facial edema, diminished strength of deep tendon reflexes, and respiratory depression [see Warnings and Precautions (5.2)].

Manufactured for:
WG Critical Care, LLC
Paramus, NJ 07652

Made in Switzerland

PRINCIPAL DISPLAY PANEL — 100 mL Bag Overwrap

NDC 44567-410-24 100 mL

Magnesium Sulfate
in 5% Dextrose Injection, USP
(0.081 mEq Mg++/mL) 10 mg/mL

1 g Total

Magnesium Sulfate in 5% Dextrose Injection, USP 1 g Total bag label image
(click image for full-size original)
MAGNESIUM SULFATE
magnesium sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44567-410
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MAGNESIUM SULFATE HEPTAHYDRATE (MAGNESIUM CATION) MAGNESIUM SULFATE HEPTAHYDRATE 1 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44567-410-24 24 BAG in 1 CARTON contains a BAG
1 100 mL in 1 BAG This package is contained within the CARTON (44567-410-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207349 03/08/2016
Labeler — WG Critical Care, LLC (829274633)
Registrant — HQ Specialty Pharma Corporation (962364332)
Establishment
Name Address ID/FEI Operations
InfoRLife SA 481732753 MANUFACTURE (44567-410)

Revised: 08/2019 WG Critical Care, LLC

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