FDA.reportPublic FDA data

FDA label 41e317e9-9ec5-48c1-8b2f-ed4a29dd40b9

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
d2acf631-fb29-475f-9b35-64f80f667a8b
SPL ID
41e317e9-9ec5-48c1-8b2f-ed4a29dd40b9
Version
2
Effective date
2014-05-12
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:53

Boxed warning cross-check#

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

boxed warning

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNING: Daily ingestion of more than 3 grams per day of omega-3 fatty acids (ALA, EPA, and DHA) may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be avoided in patients with inherited or acquired bleeding diathesis, including those taking anticoagulants. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS: Allergic sensitization has 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.