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
- 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
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 | eff3383d-a004-4293-b3b9-c10ccb016d23 | id | |
| spl set id | e83b2dd3-a9a0-40bc-ade4-6cd4db433b06 | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
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 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.