Magnesium Sulfate
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Magnesium Sulfate
- Generic name
- MAGNESIUM SULFATE HEPTAHYDRATE
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 647ca293-9e68-4773-947a-0fb064aa6fd1
- SPL ID
- 36bf495e-3966-8317-e063-6294a90a055f
- Version
- 1
- Effective date
- 2025-06-04
- Source export date
- 2026-09-28
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:26:17
| Harmonized routes |
|---|
| INTRAMUSCULAR, INTRAVENOUS |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 219777 | derived:openfda.application_number |
| application number | ANDA219777 | openfda.application_number | |
| brand name | Magnesium Sulfate | openfda.brand_name | |
| generic name | MAGNESIUM SULFATE HEPTAHYDRATE | openfda.generic_name | |
| manufacturer name | Camber Pharmaceuticals, Inc. | openfda.manufacturer_name | |
| ndc | package | 31722-394-32 | openfda.package_ndc |
| ndc | package | 31722-394-35 | openfda.package_ndc |
| ndc | package | 31722-394-10 | openfda.package_ndc |
| ndc | package | 31722-394-31 | openfda.package_ndc |
| ndc | package | 31722-394-33 | openfda.package_ndc |
| ndc | package | 31722-394-20 | openfda.package_ndc |
| ndc | package | 31722-394-50 | openfda.package_ndc |
| ndc | package | 31722-394-34 | openfda.package_ndc |
| ndc | product | 31722-394 | openfda.product_ndc |
| ndc11 | package | 31722039434 | derived:openfda.package_ndc |
| ndc11 | package | 31722039433 | derived:openfda.package_ndc |
| ndc11 | package | 31722039410 | derived:openfda.package_ndc |
| ndc11 | package | 31722039420 | derived:openfda.package_ndc |
| ndc11 | package | 31722039432 | derived:openfda.package_ndc |
| ndc11 | package | 31722039435 | derived:openfda.package_ndc |
| ndc11 | package | 31722039450 | derived:openfda.package_ndc |
| ndc11 | package | 31722039431 | derived:openfda.package_ndc |
| rxcui | 1658244 | openfda.rxcui | |
| rxcui | 1658245 | openfda.rxcui | |
| rxcui | 1658236 | openfda.rxcui | |
| rxcui | 1658221 | openfda.rxcui | |
| spl id | 36bf495e-3966-8317-e063-6294a90a055f | id | |
| spl set id | 647ca293-9e68-4773-947a-0fb064aa6fd1 | set_id | |
| unii | SK47B8698T | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: FETAL HARM: Continuous administration of magnesium sulfate beyond 5 to 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 to 7 days may cause fetal abnormalities. ALUMINUM TOXICITY: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Parenteral use in the presence of renal insufficiency may lead to magnesium intoxication. IV use in eclampsia should be reserved for immediate control of life-threatening convulsions.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: 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 CNS depression proceeding to respiratory paralysis. Hypocalcemia with signs of tetany secondary to magnesium sulfate therapy for eclampsia has been reported.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.