Mannitol
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
- Mannitol
- Generic name
- MANNITOL
- Manufacturer
- Fresenius Kabi USA, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- c395e13d-6ea1-4104-8b37-669cfb982f04
- SPL ID
- fe8beed4-a8db-400e-834e-b5efe2f5af1c
- Version
- 4
- Effective date
- 2023-03-16
- 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 06:24:10
| Harmonized routes |
|---|
| 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 | 080677 | derived:openfda.application_number |
| application number | ANDA080677 | openfda.application_number | |
| brand name | Mannitol | openfda.brand_name | |
| generic name | MANNITOL | openfda.generic_name | |
| manufacturer name | Fresenius Kabi USA, LLC | openfda.manufacturer_name | |
| ndc | package | 63323-024-25 | openfda.package_ndc |
| ndc | package | 63323-024-01 | openfda.package_ndc |
| ndc | product | 63323-024 | openfda.product_ndc |
| ndc11 | package | 63323002401 | derived:openfda.package_ndc |
| ndc11 | package | 63323002425 | derived:openfda.package_ndc |
| rxcui | 311450 | openfda.rxcui | |
| spl id | fe8beed4-a8db-400e-834e-b5efe2f5af1c | id | |
| spl set id | c395e13d-6ea1-4104-8b37-669cfb982f04 | set_id | |
| unii | 3OWL53L36A | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS In severe impairment of renal function a test dose should be given (see DOSAGE AND ADMINISTRATION ). A second test dose may be given if there is an inadequate response. No more than two test doses should be attempted. Excessive loss of water and electrolytes may lead to serious imbalances. Serum sodium and potassium should be carefully monitored during mannitol therapy. The diuresis after rapid infusion of mannitol may increase preexisting hemoconcentration. With continued use of mannitol a loss of water in excess of electrolytes can cause hypernatremia. Shift of sodium-free intracellular fluid into the extracellular compartment after mannitol infusion may lower serum sodium concentration and aggravate preexisting hyponatremia. Closely monitor the urine output and discontinue mannitol infusion promptly if output is low. Inadequate urine output results in accumulation of mannitol, expansion of extracellular fluid volume and could result in water intoxication or congestive heart failure. Renal function must be closely monitored during mannitol infusion. Mannitol solution must be used with caution in patients with significant cardiopulmonary or renal dysfunction. Irrigating solutions used in transurethral prostatectomy have been shown to enter the systemic circulation in relatively large volumes, exert a systemic effect and may significantly alter cardiopulmonary and renal dynamics.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Reactions are infrequent and may include: To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Metabolic: fluid and electrolyte imbalance, acidosis, dehydration. Gastrointestinal: dryness of mouth, nausea, vomiting, diarrhea. Genitourinary: osmotic nephrosis, urinary retention. Central Nervous System: headache, convulsions, dizziness. Special Senses: Blurred vision, rhinitis. Cardiovascular: pulmonary edema, edema, hypotension, hypertension, tachycardia, angina-like chest pains. Dermatologic: skin necrosis, thrombophlebitis. Hypersensitivity: urticaria. Miscellaneous: thirst, arm pain, chills, fever.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.