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 (canonical bytes are SHA-256 checked before publication)

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

Boxed warning cross-check#

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Boxed warning sections page 1 of 1 · 2 matching rows.

boxed warning

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#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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.