FDA label 745a33b8-2e21-455e-ae6d-97f38e68d3cb
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
- SPL set ID
- 647f2dda-26be-4a86-b5aa-2f9ec1c9c8e3
- SPL ID
- 745a33b8-2e21-455e-ae6d-97f38e68d3cb
- Version
- 3
- Effective date
- 2017-07-18
- Source export date
- 2026-10-12
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:26:21
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 |
|---|---|---|---|
| spl id | 745a33b8-2e21-455e-ae6d-97f38e68d3cb | id | |
| spl set id | 647f2dda-26be-4a86-b5aa-2f9ec1c9c8e3 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Magnesium Sulfate should be given very cautiously in the presence of serious impairment of renal function since it is excreted almost entirely by the kidneys. The principle hazard in parenteral magnesium therapy is the production of abnormally high levels of magnesium in the plasma. Such high levels may cause flushing, sweating, hypotension, circulatory collapse and depression of cardiac and central nervous system function. The most immediate danger to life is respiratory depression. During the period of parenteral therapy with magnesium salts, the patient should be watched carefully. A preparation of calcium, such as the gluconate or gluceptate should be at hand for intravenous administration as an antidote. In the presence of severe renal insufficiency, no more than 20 grams of magnesium should be given within a forty-eight hour period. In eclampsia, however, renal function is not seriously impaired and magnesium may be more rapidly excreted. 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.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Flushing, sweating, sharply lowered blood pressure, hypothermia, stupor and ultimately, respiratory depression. 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.