FDA.reportPublic FDA data

PNV-DHA

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)

Brand name
PNV-DHA
Generic name
ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CALCIUM, FERROUS FUMARATE, DOCONEXENT
Manufacturer
Acella Pharmaceuticals, LLC
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
576e8bbb-1625-493c-85da-43caf2f02e3c
SPL ID
4c39225d-b6a1-5de2-e063-6294a90aa552
Version
4
Effective date
2026-03-04
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:37:11
Harmonized routes table
Harmonized routes
ORAL

Boxed warning cross-check#

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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

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. CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 grams (1000 mg) daily.

Reported adverse events (FAERS/openFDA)#

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