FDA label 49db9b42-43ff-4013-b562-8ef486a6fc1f
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
- e3b1a962-fef4-4104-b23d-c7b492372918
- SPL ID
- 49db9b42-43ff-4013-b562-8ef486a6fc1f
- Version
- 4
- Effective date
- 2020-11-17
- Source export date
- 2026-10-12
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:42:02
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 | 49db9b42-43ff-4013-b562-8ef486a6fc1f | id | |
| spl set id | e3b1a962-fef4-4104-b23d-c7b492372918 | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNING USE OF THIS PRODUCT WITHOUT DIRECT SUPERVISION OF A PHYSICIAN IS DANGEROUS ; Some patients afflicted with pernicious anemia may or not respond to the orally ingested vitamin B 12 , and there is no known way to predict which patients may respond and which patients may cease to respond; Periodic examinations and laboratory studies of pernicious anemia patients are essential and recommended ; and - The parenteral administration of (cyano) cobalamin - or vitamin B12, is generally recognized as a fully effective treatment of pernicious anemia. Parenteral alkyl -cobalamin preparations have not been and are not authorized for use except by or on the prescription of a physician.
boxed warning table
<table cellspacing="0" cellpadding="0"><tbody><tr><td><list listType="ordered"><item><content styleCode="bold">USE OF THIS PRODUCT WITHOUT DIRECT SUPERVISION OF A PHYSICIAN IS DANGEROUS</content>;</item><item><content styleCode="italics">Some patients afflicted with pernicious anemia may or not respond to the orally ingested vitamin B</content><content styleCode="italics">12</content><content styleCode="italics">, and there is no known way to predict which patients may respond and which patients may cease to respond;</content></item><item><content styleCode="bold">Periodic examinations and laboratory studies of pernicious anemia patients are essential and recommended</content> ; and -</item><item><content>The parenteral administration of </content><content styleCode="italics">(cyano)</content><content>cobalamin - or vitamin B12, is generally recognized as a fully effective treatment of pernicious anemia. Parenteral </content><content styleCode="italics">alkyl</content><content>-cobalamin preparations have not been and are not authorized for use except by or on the prescription of a physician.</content></item></list></td></tr></tbody></table>
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, feeling of swelling of entire body may occur with administration of cobalamin. Allergic sensitization has been reported following both oral and parenteral administration of folate.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.