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Magnesium Water Prescribing Information

Package insert / product label
Generic name: magnesium sulfate heptahydrate in water for injection
Dosage form: injection, solution
Drug classes: Laxatives, Minerals and electrolytes, Miscellaneous anticonvulsants
J Code (medical billing code): J3475 (500 mg, injection)

Medically reviewed by Drugs.com. Last updated on Oct 29, 2023.

Flexible Plastic Container

For Intravenous Use Only

Rx only

Magnesium Water Description

Magnesium Sulfate in Water for Injection is a sterile, nonpyrogenic solution of magnesium sulfate heptahydrate in water for injection. May contain sulfuric acid and/or sodium hydroxide for pH adjustment. The pH is 4.5 (3.5 to 6.5). It is available in 4% and 8% concentrations. See HOW SUPPLIED section for the content and characteristics of available dosage forms and sizes.

Magnesium Sulfate, USP heptahydrate is chemically designated MgSO4 • 7H2O, colorless crystals or white powder freely soluble in water.

Water for Injection, USP is chemically designated H2O.

Water can permeate from inside the flexible plastic container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Magnesium Water - Clinical Pharmacology

Magnesium (Mg++) is an important cofactor for enzymatic reactions and plays an important role in neurochemical transmission and muscular excitability.

Magnesium prevents or controls convulsions by blocking neuromuscular transmission and decreasing the amount of acetylcholine liberated at the end plate by the motor nerve impulse. Magnesium is said to have a depressant effect on the central nervous system, but it does not adversely affect the mother, fetus or neonate when used as directed in eclampsia or pre-eclampsia. Normal serum magnesium levels range from 1.3 to 2.1 mEq/liter.

As serum magnesium rises above 4 mEq/liter, the deep tendon reflexes are first decreased and then disappear as the serum level approaches 10 mEq/liter. At this level respiratory paralysis may occur. Heart block also may occur at this or lower serum levels of magnesium.

Magnesium acts peripherally to produce vasodilation. With low doses only flushing and sweating occur, but larger doses cause lowering of blood pressure. The central and peripheral effects of magnesium poisoning are antagonized to some extent by intravenous administration of calcium.

With intravenous administration the onset of anticonvulsant action is immediate and lasts about 30 minutes. Following intramuscular administration the onset of action occurs in about one hour and persists for three to four hours. Effective anticonvulsant serum levels range from 2.5 to 7.5 mEq/liter.

Pharmacokinetics:

Absorption: Intravenously administered magnesium is immediately absorbed.

Distribution: Approximately 1-2% of total body magnesium is located in the extracellular fluid space. Magnesium is 30% bound to albumin.

Metabolism: Magnesium is not metabolized.

Excretion: Magnesium is excreted solely by the kidney at a rate proportional to the serum concentration and glomerular filtration.

Special Populations:

Renal Insufficiency: Magnesium is excreted solely by the kidney. In patients with severe renal insufficiency, the dose should be lower and frequent serum magnesium levels must be obtained (see DOSAGE AND ADMINISTRATION).

Hepatic Insufficiency: Magnesium is excreted solely by the kidney. No dosing adjustments are necessary in hepatic insufficiency.

Drug-Drug Interactions: Drug induced renal losses of magnesium occur with the following drugs or drug classes:

Aminoglycosides Amphotericin B
Cyclosporine Diuretics
Digitalis Cisplatin
Alcohol

Indications and Usage for Magnesium Water

Magnesium Sulfate in Water for Injection is indicated for the prevention and control of seizures in preeclampsia and eclampsia, respectively. When used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant. However, other effective drugs are available for this purpose.

Contraindications

Intravenous magnesium should not be given to mothers with toxemia of pregnancy during the two hours preceding delivery.

Warnings

FETAL HARM: Continuous administration of magnesium sulfate beyond 5-7 days to pregnant women can lead to hypocalcemia and bone abnormalities in the developing fetus. These bone abnormalities include skeletal demineralization and osteopenia. In addition, cases of neonatal fracture have been reported. The shortest duration of treatment that can lead to fetal harm is not known. Magnesium sulfate should be used during pregnancy only if clearly needed. If magnesium sulfate is given for treatment of preterm labor, the woman should be informed that the efficacy and safety of such use have not been established and that use of magnesium sulfate beyond 5-7 days may cause fetal abnormalities.

Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication.

Precautions

Because magnesium is removed from the body solely by the kidneys, the drug should be used with caution in patients with renal impairment. Urine output should be maintained at a level of 100 mL every four hours. Monitoring serum magnesium levels and the patient’s clinical status is essential to avoid the consequences of overdosage in toxemia. Clinical indications of a safe dosage regimen include the presence of the patellar reflex (knee jerk) and absence of respiratory depression (approximately 16 breaths or more/minute). Serum magnesium levels usually sufficient to control convulsions range from 3 to 6 mg/100 mL (2.5 to 5 mEq/liter). The strength of the deep tendon reflexes begins to diminish when serum magnesium levels exceed 4 mEq/liter. Reflexes may be absent at 10 mEq magnesium/liter, where respiratory paralysis is a potential hazard. An injectable calcium salt should be immediately available to counteract the potential hazards of magnesium intoxication in eclampsia.

Magnesium Sulfate in Water for Injection should be administered slowly to avoid producing hypermagnesemia.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Magnesium Sulfate in Water for Injection have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy (See WARNINGS and PRECAUTIONS)

Teratogenic Effects:

Magnesium Sulfate in Water for Injection, can cause fetal abnormalities when administered beyond 5-7 days to pregnant women. There are retrospective epidemiological studies and case reports documenting fetal abnormalities such as hypocalcemia, skeletal demineralization’s, osteopenia and other l skeletal abnormalities with continuous maternal administration of magnesium sulfate for more than 5-7 days.1-12 Magnesium Sulfate in Water for Injection should be used during pregnancy only if clearly needed. If this drug is used during pregnancy the woman should be apprised of the potential harm to the fetus.

Nonteratogenic Effects:

When administered by continuous IV infusion (especially for more than 24 hours preceding delivery) to control convulsions in a toxemic woman, the newborn may show signs of magnesium toxicity, including neuromuscular or respiratory depression. (See OVERDOSAGE.)

Labor and Delivery:

Continuous administration of magnesium sulfate is an unapproved treatment for preterm labor. The safety and efficacy of such use have not been established. The administration of Magnesium Sulfate in Water for Injection outside of its approved indication in pregnant women should be by trained obstetrical personnel in a hospital setting with appropriate obstetrical care facilities.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Magnesium Sulfate in Water for Injection is administered to a nursing mother.

Adverse Reactions/Side Effects

The adverse effects of parenterally administered magnesium usually are the result of magnesium intoxication. These include flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system depression proceeding to respiratory paralysis.

Hypocalcemia with signs of tetany secondary to magnesium sulfate therapy for eclampsia has been reported.

Overdosage

Magnesium intoxication is manifested by a sharp drop in blood pressure and respiratory paralysis. Disappearance of the patellar reflex is a useful clinical sign to detect the onset of magnesium intoxication. In the event of overdosage, artificial ventilation must be provided until a calcium salt can be injected IV to antagonize the effects of magnesium.

For Treatment of Overdose

Artificial respiration is often required. Intravenous calcium, 10 to 20 mL of a 5% solution (diluted if desirable) with isotonic sodium chloride for injection) is used to counteract effects of hypermagnesemia. Subcutaneous physostigmine, 0.5 to 1 mg may be helpful.

Hypermagnesemia in the newborn may require resuscitation and assisted ventilation via endotracheal intubation or intermittent positive pressure ventilation as well as IV calcium.

Magnesium Water Dosage and Administration

Magnesium Sulfate in Water for Injection is intended for intravenous use only. For the management of pre-eclampsia or eclampsia, intravenous infusions of dilute solutions of magnesium (1% to 8%) are often given in combination with intramuscular injections of 50% Magnesium Sulfate Injection, USP. Therefore, in the clinical conditions cited below, both forms of therapy are noted, as appropriate.

Continuous maternal administration of magnesium sulfate in pregnancy beyond 5-7 days can cause fetal abnormalities.

In Eclampsia

In severe pre-eclampsia or eclampsia, the total initial dose is 10 to 14 g of magnesium sulfate. To initiate therapy, 4 g of Magnesium Sulfate in Water for Injection may be administered intravenously. The rate of I.V. infusion should generally not exceed 150 mg/minute, or 3.75 mL of a 4% concentration (or its equivalent) per minute, except in severe eclampsia with seizures. Simultaneously, 4 to 5 g (32.5 to 40.6 mEq) of magnesium sulfate may be administered intramuscularly into each buttock using undiluted 50% Magnesium Sulfate Injection, USP. After the initial I.V. dose, some clinicians administer 1 to 2 g/hour by constant I.V. infusion.

Subsequent intramuscular doses of 4 to 5 g of magnesium sulfate may be injected into alternate buttocks every four hours, depending on the continuing presence of the patellar reflex, adequate respiratory function, and absence of signs of magnesium toxicity. Therapy should continue until paroxysms cease.

A serum magnesium level of 6 mg/100 mL is considered optimal for control of seizures. A total daily (24 hr) dose of 30 to 40 g magnesium sulfate should not be exceeded. In the presence of severe renal insufficiency, frequent serum magnesium concentrations must be obtained and the maximum dosage of magnesium sulfate is 20 g per 48 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Do not administer unless solution is clear. Discard unused portion.

How is Magnesium Water supplied

Magnesium Sulfate in Water for Injection is supplied in single-dose flexible plastic containers as follows:

NDC Number
(Unit of Sale)
ConcentrationTotal Magnesium Sulfate*Total Magnesium IonMagnesium Sulfate* ConcentrationMagnesium Ion ConcentrationOsmolarity (calc.)
*
As the heptahydrate.
Partial fill container 50 mL volume in 100 mL container.

NDC 0409-6729-23
Case of 24 single-dose flexible plastic containers

4 g/100 mL
(40 mg/mL)

4 g

32.5 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-4121-50
Case of 50 single-dose flexible plastic containers

4 g/100 mL
(40 mg/mL)

4 g

32.5 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-6729-03
Case of 24 single-dose flexible plastic containers

20 g/500 mL
(40 mg/mL)

20 g

162.3 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-2050-20
Case of 20 single-dose flexible plastic containers

20 g/500 mL
(40 mg/mL)

20 g

162.3 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-6729-09
Case of 12 single-dose flexible plastic containers

40 g/1000 mL
(40 mg/mL)

40 g

325 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-3164-12
Case of 12 single-dose flexible plastic containers

40 g/1000 mL
(40 mg/mL)

40 g

325 mEq

4% (40 mg/mL)

32.5 mEq/100 mL

325 mOsmol/Liter

NDC 0409-6729-24
Case of 24 single-dose flexible plastic containers

2 g/50 mL
(40 mg/mL)

2 g

16.25 mEq

4% (40 mg/mL)

16.25 mEq/50 mL

325 mOsmol/Liter

NDC 0409-5239-60
Case of 60 single-dose flexible plastic containers

2 g/50 mL
(40 mg/mL)

2 g

16.25 mEq

4% (40 mg/mL)

16.25 mEq/50 mL

325 mOsmol/Liter

NDC 0409-6730-13
Case of 24 single-dose flexible plastic containers

4 g/50 mL
(80 mg/mL)

4 g

32.5 mEq

8% (80 mg/mL)

32.5 mEq/50 mL

649 mOsmol/Liter

NDC 0409-6730-60
Case of 60 single-dose flexible plastic containers

4 g/50 mL
(80 mg/mL)

4 g

32.5 mEq

8% (80 mg/mL)

32.5 mEq/50 mL

649 mOsmol/Liter

WARNING: DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.

References

1.
Yokoyama K, Takahashi N, Yada Y. Prolonged maternal magnesium administration and bone metabolism in neonates. Early Human Dev. 2010; 86(3):187-91. Epub 2010 Mar 12.
2.
Wedig KE, Kogan J, Schorry EK et al. Skeletal demineralization and fractures caused by fetal magnesium toxicity. J Perinatol. 2006; 26(6):371-4.
3.
Nassar AH, Sakhel K, Maarouf H, et al. Adverse maternal and neonatal outcome of prolonged course of magnesium sulfate tocolysis. Acta Obstet Gynecol Scan. 2006;85(9):1099-103.
4.
Malaeb SN, Rassi A, Haddad MC. Bone mineralization in newborns whose mothers received magnesium sulphate for tocolysis of premature labor. Pediatr Radiol. 2004;34(5):384-6. Epub 2004 Feb 18.
5.
Matsuda Y, Maeda Y, Ito M, et al. Effect of magnesium sulfate treatment on neonatal bone abnormalities. Gynecol Obstet Invest. 1997; 44(2):82-8.
6.
Schanler RJ, Smith LG, Burns PA. Effects of long-term maternal intravenous magnesium sulfate therapy on neonatal calcium metabolism and bone mineral content. Gynecol Obstet Invest. 1997; 43(4):236-41.
7.
Santi MD, Henry GW, Douglas GL. Magnesium sulfate treatment of preterm labor as a cause of abnormal neonatal bone mineralization. J Pediatr Orthop. 1994; 14(2):249-53.
8.
Holocomb WL, Shackelford GD, Petrie RH. Magnesium tocolysis and neonatal bone abnormalities: a controlled study. Obstet Gynecol. 1991; 78(4):611-4.
9.
Cumming WA, Thomas VJ. Hypermagnesemia: a cause of abnormal metaphyses in the neonate. Am J Roentgenol. 1989; 152(5):1071-2.
10.
Lamm CL, Norton KL, Murphy RJ. Congenital rickets associated with magnesium sulfate infusion for tocolysis. J Pediatr. 1988; 113(6):1078-82.
11.
McGuinness GA, Weinstein MM, Cruikshank DP, et al. Effects of magnesium sulfate treatment on perinatal calcium metabolism. II. Neonatal responses. Obstet Gynecol. 1980;56(5):595-600.
12.
Riaz M, Porat R, Brodsky NL, et al. The effect of maternal magnesium sulfate treatment on newborns: a prospective controlled study. J Perinatol. 1998; 18(6 pt 1):449-54.
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Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

LAB-1087-3.0

Revised: 03/2022

PRINCIPAL DISPLAY PANEL - 50 mL Bag Label

50 mL
NDC 0409-6730-11

MAGNESIUM SULFATE
IN WATER FOR INJECTION
4 g/50 mL (80 mg/mL)

4g
TOTAL

EACH 50 mL CONTAINS MAGNESIUM SULFATE
HEPTAHYDRATE 4 g (EQUIVALENT TO 32.5 mEq
MAGNESIUM) IN WATER FOR INJECTION. MAY
CONTAIN SULFURIC ACID AND/OR SODIUM
HYDROXIDE FOR pH ADJUSTMENT.
pH 4.5 (3.5 to 6.5) 649 mOsmol/LITER (CALC.)
SINGLE-DOSE CONTAINER. DISCARD UNUSED
PORTION. FOR INTRAVENOUS USE.
RECOMMENDED DOSAGE: SEE PRESCRIBING
INFORMATION. STERILE, NONPYROGENIC. USE
ONLY IF SOLUTION IS CLEAR AND CONTAINER IS
UNDAMAGED. MUST NOT BE USED IN SERIES
CONNECTIONS.

Rx ONLY

IM-5199

3
V
CONTAINS DEHP

Hospira

DISTRIBUTED BY
HOSPIRA, INC., LAKE FOREST, IL 60045 USA

PRINCIPAL DISPLAY PANEL - 50 mL Bag Label

PRINCIPAL DISPLAY PANEL - 50 mL Bag Pouch Label

50 mL
TO OPEN – TEAR AT NOTCH
NDC 0409-6730-11

MAGNESIUM SULFATE
IN WATER FOR INJECTION

4 g/50 mL (80 mg/mL)

4g
TOTAL

Each 50 mL contains magnesium sulfate heptahydrate 4 g (equivalent to 32.5 mEq
magnesium) in water for injection. May contain sulfuric acid and/or sodium hydroxide
for pH adjustment.

649 mOsmol/Liter (CALC.)
pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL
ROUTE.

Single-dose container. For intravenous use. Recommended dosage: See prescribing
information. Sterile, nonpyrogenic. Use only if solution is clear. After removing the
overwrap, check for minute leaks by squeezing container firmly. If leaks are found,
discard unit as sterility may be impaired. Must not be used in series connections.
The overwrap is a moisture barrier. Do not remove unit from overwrap until ready for
use. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP
Controlled Room Temperature.] Protect from freezing. See prescribing information.
Not Made With Natural Rubber Latex.

Rx only

7
OTHER

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

F WR-1551

Hospira

PRINCIPAL DISPLAY PANEL - 50 mL Bag Pouch Label

PRINCIPAL DISPLAY PANEL - 50 mL Bag Label - NDC 0409-6730-50

50 mL
NDC 0409-6730-50
Magnesium Sulfate
in Water for Injection
4 g/50 mL (80 mg/mL)
4g
TOTAL

Each 50 mL contains magnesium sulfate heptahydrate 4 g (equivalent to
32.5 mEq magnesium) in water for injection. May contain sulfuric acid
and/or sodium hydroxide for pH adjustment.
pH 4.5 (3.5 to 6.5)
649 mOsmol/Liter (CALC.)
Single-dose container. Discard unused portion. For intravenous use.
Recommended dosage: See prescribing information. Sterile, nonpyrogenic.
Use only if solution is clear and container is undamaged. Must not be used in
series connections.

Rx ONLY

5
PP

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

Hospira

12165-02

LOT:12345678
EXP:mm-yyyy

PRINCIPAL DISPLAY PANEL - 50 mL Bag Label - NDC 0409-6730-50

PRINCIPAL DISPLAY PANEL - 50 mL Bag Pouch Label - NDC 0409-6730-50

50 mL
NDC 0409-6730-50

Magnesium Sulfate

in Water for Injection
4 g/50 mL (80 mg/mL)
4 g
TOTAL

Each 50 mL contains magnesium sulfate heptahydrate 4 g
(equivalent to 32.5 mEq magnesium) in water for injection. May
contain sulfuric acid and/or sodium hydroxide for pH adjustment.
649 mOsmol/Liter (CALC.)
pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER
POSSIBLE USE CENTRAL ROUTE.

Single-dose container. For intravenous use. Recommended dosage:
See prescribing information. Sterile, nonpyrogenic. Use only if
solution is clear. After removing the overwrap, check for minute
leaks by squeezing container firmly. If leaks are found, discard unit
as sterility may be impaired. Must not be used in series connections.
The overwrap is a moisture barrier. Do not remove unit from
overwrap until ready for use. Use unit promptly when pouch is
opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room
Temperature.] Protect from freezing. See prescribing information.

Not Made With Natural Rubber Latex.

Rx ONLY

7
OTHER

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

Hospira

13090-01

PRINCIPAL DISPLAY PANEL - 50 mL Bag Pouch Label - NDC 0409-6730-50

PRINCIPAL DISPLAY PANEL - 50 mL Bag Overwrap Back

Magnesium
Sulfate

in Water for Injection
4 g/50 mL
(80 mg/mL)
4 g
TOTAL

13088-01

PRINCIPAL DISPLAY PANEL - 50 mL Bag Overwrap Back

PRINCIPAL DISPLAY PANEL - 100 mL Bag Label

100 mL
NDC 0409-6729-41

MAGNESIUM SULFATE
IN WATER FOR INJECTION

4 g/100 mL (40 mg/mL)

4g
TOTAL

EACH 100 mL CONTAINS MAGNESIUM SULFATE
HEPTAHYDRATE 4 g (EQUIVALENT TO 32.5 mEq
MAGNESIUM) IN WATER FOR INJECTION. MAY
CONTAIN SULFURIC ACID AND/OR SODIUM
HYDROXIDE FOR pH ADJUSTMENT.
pH 4.5 (3.5 to 6.5) 325 mOsmol/LITER (CALC.)
SINGLE-DOSE CONTAINER. DISCARD UNUSED
PORTION. FOR INTRAVENOUS USE.
RECOMMENDED DOSAGE: SEE PRESCRIBING
INFORMATION. STERILE, NONPYROGENIC. USE
ONLY IF SOLUTION IS CLEAR AND CONTAINER IS
UNDAMAGED. MUST NOT BE USED IN SERIES
CONNECTIONS.

Rx ONLY

IM-5198

3
V
CONTAINS DEHP

Hospira

DISTRIBUTED BY
HOSPIRA, INC., LAKE FOREST, IL 60045 USA

PRINCIPAL DISPLAY PANEL - 100 mL Bag Label

PRINCIPAL DISPLAY PANEL - 100 mL Bag Pouch Label

100 mL
TO OPEN – TEAR AT NOTCH
NDC 0409-6729-41

MAGNESIUM SULFATE
IN WATER FOR INJECTION

4 g/100 mL (40 mg/mL)

4g
TOTAL

Each 100 mL contains magnesium sulfate heptahydrate 4 g (equivalent to 32.5 mEq
magnesium) in water for injection. May contain sulfuric acid and/or sodium hydroxide
for pH adjustment.

325 mOsmol/Liter (CALC.)
pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL
ROUTE.

Single-dose container. For intravenous use. Recommended dosage: See prescribing
information. Sterile, nonpyrogenic. Use only if solution is clear. After removing the
overwrap, check for minute leaks by squeezing container firmly. If leaks are found,
discard unit as sterility may be impaired. Must not be used in series connections.
The overwrap is a moisture barrier. Do not remove unit from overwrap until ready for
use. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP
Controlled Room Temperature.] Avoid excessive heat. Protect from freezing. See
prescribing information.
Not Made With Natural Rubber Latex.

Rx only

7
OTHER

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

F WR-1550

Hospira

PRINCIPAL DISPLAY PANEL - 100 mL Bag Pouch Label

PRINCIPAL DISPLAY PANEL - 500 mL Bag Label

500 mL
NDC 0409-6729-21

20 g
TOTAL

MAGNESIUM
SULFATE

IN WATER FOR INJECTION
20 g/500 mL (40 mg/mL)

EACH 100 mL CONTAINS MAGNESIUM SULFATE
HEPTAHYDRATE 4 g (EQUIVALENT TO 32.5 mEq
MAGNESIUM) IN WATER FOR INJECTION. MAY CONTAIN
SULFURIC ACID AND/OR SODIUM HYDROXIDE FOR pH
ADJUSTMENT.

pH 4.5 (3.5 to 6.5)
325 mOsmol/LlTER (CALC.)

SINGLE-DOSE CONTAINER. DISCARD UNUSED PORTION.
FOR INTRAVENOUS USE. RECOMMENDED DOSAGE: SEE
PRESCRIBING INFORMATION. STERILE, NONPYROGENIC.
USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS
UNDAMAGED. MUST NOT BE USED IN SERIES
CONNECTIONS.

Rx ONLY

3
V
CONTAINS DEHP

Hospira

IM-5196

DISTRIBUTED BY
HOSPIRA, INC., LAKE FOREST, IL 60045 USA

PRINCIPAL DISPLAY PANEL - 500 mL Bag Label

PRINCIPAL DISPLAY PANEL - 40 mg/mL Bag Overwrap - 500 mL

TO OPEN TEAR AT NOTCH

2
HDPE

DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING
THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY.
IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.
RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE
HEAT. PROTECT FROM FREEZING. SEE INSERT.
98-4321-R14-3/98

PRINCIPAL DISPLAY PANEL - 40 mg/mL Bag Overwrap - 500 mL

PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label

1000 mL
NDC 0409-6729-31

MAGNESIUM
SULFATE
IN WATER FOR
INJECTION

40 g
TOTAL

40 g/1000 mL (40 mg/mL)

EACH 100 mL CONTAINS MAGNESIUM
SULFATE HEPTAHYDRATE 4 g (EQUIVALENT
TO 32.5 mEq MAGNESIUM) IN WATER FOR
INJECTION. MAY CONTAIN SULFURIC ACID
AND/OR SODIUM HYDROXIDE FOR pH
ADJUSTMENT.

pH 4.5 (3.5 to 6.5)
325 mOsmol/LITER (CALC.)

SINGLE-DOSE CONTAINER. DISCARD
UNUSED PORTION. FOR INTRAVENOUS
USE. RECOMMENDED DOSAGE: SEE
PRESCRIBING INFORMATION. STERILE,
NONPYROGENIC. USE ONLY IF SOLUTION
IS CLEAR AND CONTAINER IS
UNDAMAGED. MUST NOT BE USED IN
SERIES CONNECTIONS.

Rx ONLY

3
V
CONTAINS DEHP

DISTRIBUTED BY
HOSPIRA, INC., LAKE FOREST, IL 60045 USA

IM-5197

Hospira

PRINCIPAL DISPLAY PANEL - 1000 mL Bag Label

PRINCIPAL DISPLAY PANEL - 40 mg/mL Bag Overwrap - 1000 mL

TO OPEN TEAR AT NOTCH

2
HDPE

DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING
THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY.
IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.
RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVE
HEAT. PROTECT FROM FREEZING. SEE INSERT.
98-4321-R14-3/98

PRINCIPAL DISPLAY PANEL - 40 mg/mL Bag Overwrap - 1000 mL

PRINCIPAL DISPLAY PANEL - 2 g/50 mL Bag Label

50 mL
NDC 0409-6729-11

MAGNESIUM SULFATE
IN WATER FOR INJECTION

2g
TOTAL

2 g/50 mL (40 mg/mL)

EACH 50 mL CONTAINS MAGNESIUM SULFATE
HEPTAHYDRATE 2 g (EQUIVALENT TO 16.25 mEq
MAGNESIUM) IN WATER FOR INJECTION. MAY
CONTAIN SULFURIC ACID AND/OR SODIUM
HYDROXIDE FOR pH ADJUSTMENT.

pH 4.5 (3.5 to 6.5) 325 mOsmol/LITER (CALC.)

SINGLE-DOSE CONTAINER. DISCARD UNUSED
PORTION. FOR INTRAVENOUS USE.
RECOMMENDED DOSAGE: SEE PRESCRIBING
INFORMATION. STERILE, NONPYROGENIC. USE
ONLY IF SOLUTION IS CLEAR AND CONTAINER IS
UNDAMAGED. MUST NOT BE USED IN SERIES
CONNECTIONS.

Rx ONLY

3
V
CONTAINS DEHP

Hospira

IM-5195

DISTRIBUTED BY HOSPIRA, INC.,
LAKE FOREST, IL 60045 USA

PRINCIPAL DISPLAY PANEL - 2 g/50 mL Bag Label

PRINCIPAL DISPLAY PANEL - 2 g/50 mL Bag Pouch Label

50 mL
TO OPEN – TEAR AT NOTCH
NDC 0409-6729-11

MAGNESIUM SULFATE
IN WATER FOR INJECTION

2 g
TOTAL

2 g/50 mL (40 mg/mL)

Each 50 mL contains magnesium sulfate heptahydrate 2 g (equivalent to 16.25 mEq
magnesium) in water for injection. May contain sulfuric acid and/or sodium hydroxide
for pH adjustment.

325 mOsmol/Liter (CALC.)
pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER POSSIBLE USE CENTRAL
ROUTE.

Single-dose container. For intravenous use. Recommended dosage: See prescribing
information. Sterile, nonpyrogenic. Use only if solution is clear. After removing the
overwrap, check for minute leaks by squeezing container firmly. If leaks are found,
discard unit as sterility may be impaired. Must not be used in series connections.
The overwrap is a moisture barrier. Do not remove unit from overwrap until ready for
use. Use unit promptly when pouch is opened. Store at 20 to 25°C (68 to 77°F). [See USP
Controlled Room Temperature.] Protect from freezing. See prescribing information. Not
Made With Natural Rubber Latex

Rx only

7
OTHER

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

F WR-1549

Hospira

PRINCIPAL DISPLAY PANEL - 2 g/50 mL Bag Pouch Label

PRINCIPAL DISPLAY PANEL - 4 g/100 mL Bag Label

100 mL
NDC 0409-4121-01

Magnesium Sulfate
in Water for Injection

4 g
TOTAL

4 g/100 mL (40 mg/mL)

Each 100 mL contains magnesium sulfate heptahydrate 4 g (equivalent to
32.5 mEq magnesium) in water for injection. May contain sulfuric acid
and/or sodium hydroxide for pH adjustment.

pH 4.5 (3.5 to 6.5)
325 mOsmol/liter (CALC.)

Single-dose container. Discard unused portion. For intravenous use.
Recommended dosage: see prescribing information. Sterile, nonpyrogenic.
Use only if solution is clear and container is undamaged. Must not be used in
series connections.

Rx ONLY

5
PP

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

Hospira

12137-02

LOT:12345678
EXP:mm-yyyy

PRINCIPAL DISPLAY PANEL - 4 g/100 mL Bag Label

PRINCIPAL DISPLAY PANEL - 4 g/100 mL Bag Pouch Label

100 mL
NDC 0409-4121-01

Magnesium Sulfate

in Water for Injection
4 g/100 mL (40 mg/mL)

4 g
TOTAL

Each 100 mL contains magnesium sulfate heptahydrate 4 g
(equivalent to 32.5 mEq magnesium) in water for injection. May
contain sulfuric acid and/or sodium hydroxide for pH adjustment.

325 mOsmol/Liter (CALC.)
pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER
POSSIBLE USE CENTRAL ROUTE.

Single-dose container. For intravenous use. Recommended dosage:
See prescribing information. Sterile, nonpyrogenic. Use only if
solution is clear. After removing the overwrap, check for minute
leaks by squeezing container firmly. If leaks are found, discard unit
as sterility may be impaired. Must not be used in series connections.
The overwrap is a moisture barrier. Do not remove unit from overwrap
until ready for use. Use unit promptly when pouch is opened. Store at
20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Avoid
excessive heat. Protect from freezing. See prescribing information.

Not Made With Natural Rubber Latex

Rx ONLY

7
OTHER

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

Hospira

13093-01

PRINCIPAL DISPLAY PANEL - 4 g/100 mL Bag Pouch Label

PRINCIPAL DISPLAY PANEL - 100 mL Bag Overwrap Back

Magnesium
Sulfate

in Water for Injection
4 g/100 mL
(40 mg/mL)
4 g
TOTAL

13097-01

PRINCIPAL DISPLAY PANEL - 100 mL Bag Overwrap Back

PRINCIPAL DISPLAY PANEL - 20 g/500 mL Bag Label

500 mL
NDC 0409-2050-01

Magnesium
Sulfate
in Water for Injection

20 g
TOTAL

20 g/500 mL (40 mg/mL)

Each 100 mL contains magnesium sulfate heptahydrate
4 g (equivalent to 32.5 mEq magnesium) in water for
injection. May contain sulfuric acid and/or sodium
hydroxide for pH adjustment. pH 4.5 (3.5 to 6.5)
325 mOsmol/Liter (CALC.)
Single-dose container. Discard unused portion. For
intravenous use. Recommended dosage: see prescribing
information. Sterile, nonpyrogenic. Use only if solution is
clear and container is undamaged. Must not be used in
series connections. Inspect bag by squeezing firmly. If
leaks are found, discard.
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room
Temperature.] Protect from freezing.
Do not remove from overwrap until ready for use.

Rx ONLY

5
PP

Hospira

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

12145-02

LOT:12345678
EXP:mm-yyyy

PRINCIPAL DISPLAY PANEL - 20 g/500 mL Bag Label

PRINCIPAL DISPLAY PANEL - 40 g/1000 mL Bag Label

1000 mL
NDC 0409-3164-01

Magnesium
Sulfate
in Water for Injection

40 g
TOTAL

40 g/1000 mL (40 mg/mL)

Each 100 mL contains magnesium sulfate
heptahydrate 4 g (equivalent to 32.5 mEq
magnesium) in water for injection. May
contain sulfuric acid and/or sodium hydroxide
for pH adjustment. pH 4.5 (3.5 to 6.5)

325 mOsmol/Liter (CALC.)
Single-dose container. Discard unused portion.
For intravenous use.

Recommended dosage:
See prescribing information.

Sterile, nonpyrogenic. Use only if solution is
clear and container is undamaged. Must not
be used in series connections.

Inspect bag by squeezing firmly.
If leaks are found, discard.

Store at 20 to 25°C (68 to 77°F).
[See USP Controlled Room
Temperature.] Protect from freezing.

Do not remove from overwrap until ready for use.

Rx ONLY

5
PP

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

Hospira

12146-02

LOT:12345678
EXP:mm-yyyy

PRINCIPAL DISPLAY PANEL - 40 g/1000 mL Bag Label

PRINCIPAL DISPLAY PANEL -2 g/50 mL Bag Label - 0409-5239

50 mL
NDC 0409-5239-01

Magnesium Sulfate
in Water for Injection

2 g
TOTAL

2 g/50 mL (40 mg/mL)

Each 50 mL contains magnesium sulfate heptahydrate 2 g (equivalent to
16.25 mEq magnesium) in water for injection. May contain sulfuric acid
and/or sodium hydroxide for pH adjustment.

pH 4.5 (3.5 to 6.5)
325 mOsmol/liter (CALC.)

Single-dose container. Discard unused portion. For intravenous use.
Recommended dosage: see prescribing information. Sterile, nonpyrogenic.
Use only if solution is clear and container is undamaged. Must not be used in
series connections.

Rx ONLY

5
PP

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

Hospira

12136-02

LOT:12345678
EXP:mm-yyyy

PRINCIPAL DISPLAY PANEL - 2 g/50 mL Bag Label - 0409-5239

PRINCIPAL DISPLAY PANEL -2 g/50 mL Bag Pouch Label - 0409-5239

50 mL
NDC 0409-5239-01

Magnesium Sulfate

in Water for Injection
2 g/50 mL (40 mg/mL)

2 g
TOTAL

Each 50 mL contains magnesium sulfate heptahydrate 2 g
(equivalent to 16.25 mEq magnesium) in water for injection. May
contain sulfuric acid and/or sodium hydroxide for pH adjustment.

325 mOsmol/Liter (CALC.)
pH 4.5 (3.5 to 6.5)

DO NOT ADD SUPPLEMENTARY MEDICATION. WHENEVER
POSSIBLE USE CENTRAL ROUTE.

Single-dose container. For intravenous use. Recommended dosage:
See prescribing information. Sterile, nonpyrogenic. Use only if
solution is clear. After removing the overwrap, check for minute leaks
by squeezing container firmly. If leaks are found, discard unit as
sterility may be impaired. Must not be used in series connections.
The overwrap is a moisture barrier. Do not remove unit from overwrap
until ready for use. Use unit promptly when pouch is opened. Store at
20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Protect from freezing. See prescribing information.

Not Made With Natural Rubber Latex

Rx ONLY

7
OTHER

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

Hospira

13092-01

PRINCIPAL DISPLAY PANEL - 2 g/50 mL Bag Pouch Label - 0409-5239

PRINCIPAL DISPLAY PANEL - 2 g/50 mL Bag Overwrap Back

Magnesium
Sulfate

in Water for Injection
2 g/50 mL
(40 mg/mL)
2 g
TOTAL

13091-01

PRINCIPAL DISPLAY PANEL - 2 g/50 mL Bag Overwrap Back
MAGNESIUM SULFATE IN WATER
magnesium sulfate in water injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0409-6730
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE80 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
SULFURIC ACID (UNII: O40UQP6WCF)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0409-6730-1324 in 1 CASE03/31/200601/01/2023
11 in 1 POUCH
1NDC:0409-6730-1150 mL in 1 BAG; Type 0: Not a Combination Product
2NDC:0409-6730-6060 in 1 CASE12/27/2022
21 in 1 POUCH
2NDC:0409-6730-5050 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02030903/31/2006
MAGNESIUM SULFATE IN WATER
magnesium sulfate in water injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0409-6729
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE40 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
SULFURIC ACID (UNII: O40UQP6WCF)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0409-6729-2324 in 1 CASE10/13/2005
11 in 1 POUCH
1NDC:0409-6729-41100 mL in 1 BAG; Type 0: Not a Combination Product
2NDC:0409-6729-0324 in 1 CASE08/22/200502/01/2024
21 in 1 POUCH
2NDC:0409-6729-21500 mL in 1 BAG; Type 0: Not a Combination Product
3NDC:0409-6729-0912 in 1 CASE09/28/2005
31 in 1 POUCH
3NDC:0409-6729-311000 mL in 1 BAG; Type 0: Not a Combination Product
4NDC:0409-6729-2424 in 1 CASE11/21/2006
41 in 1 POUCH
4NDC:0409-6729-1150 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02030908/22/2005
MAGNESIUM SULFATE IN WATER
magnesium sulfate in water injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0409-4121
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE4 g in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
SULFURIC ACID (UNII: O40UQP6WCF)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0409-4121-5050 in 1 CASE12/27/2022
11 in 1 POUCH
1NDC:0409-4121-01100 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02030912/27/2022
MAGNESIUM SULFATE IN WATER
magnesium sulfate in water injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0409-2050
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE20 g in 500 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
SULFURIC ACID (UNII: O40UQP6WCF)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0409-2050-2020 in 1 CASE11/14/2022
11 in 1 POUCH
1NDC:0409-2050-01500 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02030911/14/2022
MAGNESIUM SULFATE IN WATER
magnesium sulfate in water injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0409-3164
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE40 g in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
SULFURIC ACID (UNII: O40UQP6WCF)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0409-3164-1212 in 1 CASE06/19/2023
11 in 1 POUCH
1NDC:0409-3164-011000 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02030906/19/2023
MAGNESIUM SULFATE IN WATER
magnesium sulfate in water injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0409-5239
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE2 g in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)
SULFURIC ACID (UNII: O40UQP6WCF)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0409-5239-6060 in 1 CASE12/27/2022
11 in 1 POUCH
1NDC:0409-5239-0150 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02030912/27/2022
Labeler - Hospira, Inc. (141588017)
Establishment
NameAddressID/FEIBusiness Operations
Hospira, Inc.093132819ANALYSIS(0409-6729, 0409-6730) , MANUFACTURE(0409-6729, 0409-6730) , PACK(0409-6729, 0409-6730) , LABEL(0409-6729, 0409-6730)