FDA.reportPublic FDA data

FDA label 7977f613-8167-c5cd-e053-2a91aa0ab259

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
3f81db69-321c-45b9-8a2a-f40c2b55e97f
SPL ID
7977f613-8167-c5cd-e053-2a91aa0ab259
Version
4
Effective date
2018-10-30
Source export date
2026-08-01
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/2026-08-01/054d07cb7b0dcd436e53c5bdecbb921b48860de8ff372c4a586941aa9821a276/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:21:04

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

WARNING AND PRECAUTIONS: Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.