FDA label e49c577e-3302-4945-ada1-695329f2b905

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
8dce6d49-4af4-4b7f-8b32-fa1c37a19afc
SPL ID
e49c577e-3302-4945-ada1-695329f2b905
Version
4
Effective date
2009-12-11
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:01

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNING Folic acid alone is improper therapy in the treatment of pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Ingestion of omega-3 fatty acids (including alpha-linolenic acid [ALA], eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] from fish oils) of more than 3 grams per day may present antithrombotic effects, including increased bleeding time. Omega-3 fatty acids including DHA and EPA should be avoided in patients with inherited or acquired bleeding diatheses. Patients taking anticoagulant drug products should consult with their physician prior to ingesting omega-3 fatty acids.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Iron: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) can occur but are usually mild and can subside with continuation of therapy. Although the absorption of iron is best when taken between meals, Renate DHA 430 mg, when taken after meals, may control occasional G.I. disturbances. Renate DHA 430 mg is best absorbed when taken at bedtime. Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at: 1-800-FDA-1088.

Reported adverse events (FAERS/openFDA)#

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