FDA.reportPublic FDA data

FDA label ac0c2adf-8368-4052-9747-eaf65c8b8c53

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
8099244d-1946-416c-b26a-a17b526eebc9
SPL ID
ac0c2adf-8368-4052-9747-eaf65c8b8c53
Version
1
Effective date
2018-05-16
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:22:22

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 Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

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. NOTICE: Contact with moisture can discolor or erode the softgel capsule. CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 g (1000 mg) daily.

Reported adverse events (FAERS/openFDA)#

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