Home FDA labels 4faa7802-74fa-e413-e063-6394a90a9a49 PRENATE DHA openFDA label record# Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
Brand name PRENATE DHA
Generic name ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, FOLIC ACID, LEVOMEFOLATE CALCIUM, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, MAGNESIUM OXIDE AND DOCONEXENT
Manufacturer Avion Pharmaceuticals, LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 8f2eca71-9a82-4a19-9206-36a04b865fe1
SPL ID 4faa7802-74fa-e413-e063-6394a90a9a49
Version 9
Effective date 2026-04-17
Source export date 2026-08-01
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/2026-08-01/5cbbf4af8f4e275ec50931155b30ffa7322568b9af8a1c936a47f6d6774862fd/drug-label-0002-of-0014.json.zip
Source manifest SHA-256 bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run 20260801T225920Z
Imported at 2026-08-01 23:02:01 Harmonized routes table Harmonized routes ORAL
Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 19 matching rows.
Type, Scope, Identifier table Type Scope Identifier Source field brand name PRENATE DHA openfda.brand_name generic name ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, FOLIC ACID, LEVOMEFOLATE CALCIUM, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, CALCIUM FORMATE, FERROUS ASPARTO GLYCINATE, MAGNESIUM OXIDE AND DOCONEXENT openfda.generic_name manufacturer name Avion Pharmaceuticals, LLC openfda.manufacturer_name ndc package 75854-312-30 openfda.package_ndc ndc product 75854-312 openfda.product_ndc ndc11 package 75854031230 derived:openfda.package_ndc spl id 4faa7802-74fa-e413-e063-6394a90a9a49 id spl set id 8f2eca71-9a82-4a19-9206-36a04b865fe1 set_id unii H7426RGB3L openfda.unii unii 935E97BOY8 openfda.unii unii ZAD9OKH9JC openfda.unii unii PQ6CK8PD0R openfda.unii unii NP3JD65NPY openfda.unii unii 3A3U0GI71G openfda.unii unii A9R10K3F2F openfda.unii unii P6YC3EG204 openfda.unii unii 68Y4CF58BV openfda.unii unii 7QWA1RIO01 openfda.unii unii 1C6V77QF41 openfda.unii
Boxed warning cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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# 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 (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# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.