FDA label eff3383d-a004-4293-b3b9-c10ccb016d23

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
e83b2dd3-a9a0-40bc-ade4-6cd4db433b06
SPL ID
eff3383d-a004-4293-b3b9-c10ccb016d23
Version
13
Effective date
2022-07-01
Source export date
2026-11-06
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/5731a8c92e1c0dd2a09d2f92b410e7a70ea29cbf6b8040a6a05e4be5b7c51f0d/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:42:47

Boxed warning cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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

boxed warning

WARNINGS: Caution: This product is not suitable for the TREATMENT of vitamin B 12 deficiency secondary to either pernicious anemia and/or gastrointestinal malabsorption (i.e., exocrine pancreatic insufficiency). Caution: The use of vitamin B 12 for the TREATMENT of anemnia without direct supervision of a physician may be dangerous. Call your medical practitioner about side effects.You may report side effects by calling 337.662-5962.KEEP THIS OUT OF THE REACH OF CHILDREN.

boxed warning table

<table width="100%"><caption/><tbody><tr styleCode="First Last"><td><list listType="ordered"><item><content styleCode="bold">Caution: This product is not suitable for the TREATMENT of vitamin B<sub>12</sub> deficiency <content styleCode="underline">secondary to either pernicious anemia and/or gastrointestinal malabsorption</content> (i.e., exocrine pancreatic insufficiency).</content></item><item><content styleCode="italics">Caution: The use of vitamin B<sub>12</sub> for the TREATMENT of anemnia without direct supervision of a physician may be dangerous.</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 vitamin B 12 . Allergic sensitization has been reported following both oral and parenteral administration of vitamin B 9 .

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.