FDA.reportPublic FDA data

FDA label 3a11164d-6eb1-4a01-8722-0086f94a85b3

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
209da0f4-93d4-4690-9f07-7829334ce012
SPL ID
3a11164d-6eb1-4a01-8722-0086f94a85b3
Version
2
Effective date
2013-02-22
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:34:46

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid especially in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations remain progressive. Concomitant use of ginger in patients with bleeding disorders, or who are on anti-coagulant or anti-platelet therapy, may increase the risk of bleeding.

Reported adverse events (FAERS/openFDA)#

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