FDA.reportPublic FDA data

FDA label 8f2f952b-70e7-4ad6-a878-cc9d1b8b9b7a

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
06c485cd-ee30-44f2-be63-bb98f8d1a907
SPL ID
8f2f952b-70e7-4ad6-a878-cc9d1b8b9b7a
Version
3
Effective date
2019-02-07
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:03:04

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

Warning: Ingestion of more than 3 grams of omega-3 fatty acids from fish oils per day may have potential antithrombotic effects, including an increased in bleeding time and INR (international normalized ratio). DHA should be avoided in patients with inherited or acquired bleeding diathesis, including those taking anticoagulants. Warning: Folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

Adverse reactions cross-check#

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

adverse reactions

Folic acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.

Reported adverse events (FAERS/openFDA)#

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