Home FDA labels 57496cd3-7dc0-9f97-e063-6294a90ae2ef 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, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT
Manufacturer Acella Pharmaceuticals, LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 038fe2e7-dc16-485c-b5fb-746db7231347
SPL ID 57496cd3-7dc0-9f97-e063-6294a90ae2ef
Version 4
Effective date 2026-07-23
Source export date 2026-10-27
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/2026-10-27/977776a6cc37ec1c77259da8a93ae161850a3aa120341096e5a03428b84d016b/drug-label-0012-of-0014.json.zip
Source manifest SHA-256 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run 20261027T193451Z
Imported at 2026-10-27 21:00:58 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 · 18 matching rows.
Type, Scope, Identifier table Type Scope Identifier Source field brand name PNV-DHA openfda.brand_name generic name ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT openfda.generic_name manufacturer name Acella Pharmaceuticals, LLC openfda.manufacturer_name ndc package 42192-321-30 openfda.package_ndc ndc product 42192-321 openfda.product_ndc ndc11 package 42192032130 derived:openfda.package_ndc spl id 57496cd3-7dc0-9f97-e063-6294a90ae2ef id spl set id 038fe2e7-dc16-485c-b5fb-746db7231347 set_id unii R5L488RY0Q openfda.unii unii I38ZP9992A openfda.unii unii 935E97BOY8 openfda.unii unii ZAD9OKH9JC openfda.unii unii PQ6CK8PD0R openfda.unii unii P6YC3EG204 openfda.unii unii SY7Q814VUP openfda.unii unii WR1WPI7EW8 openfda.unii unii KV2JZ1BI6Z 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 · 2 matching rows.
boxed warning 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.
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.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.