Home FDA labels 5737b004-3ab9-2d28-e063-6294a90a4ba0 PNV-Omega 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-Omega
Generic name ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENT
Manufacturer Acella Pharmaceuticals, LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 735c5531-137f-4cee-8c68-ae121045a8ff
SPL ID 5737b004-3ab9-2d28-e063-6294a90a4ba0
Version 6
Effective date 2026-07-22
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 06:28:22 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 · 21 matching rows.
Type, Scope, Identifier table Type Scope Identifier Source field brand name PNV-Omega openfda.brand_name generic name ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENT openfda.generic_name manufacturer name Acella Pharmaceuticals, LLC openfda.manufacturer_name ndc package 42192-332-30 openfda.package_ndc ndc product 42192-332 openfda.product_ndc ndc11 package 42192033230 derived:openfda.package_ndc spl id 5737b004-3ab9-2d28-e063-6294a90a4ba0 id spl set id 735c5531-137f-4cee-8c68-ae121045a8ff set_id unii R5L488RY0Q openfda.unii unii H0G9379FGK openfda.unii unii 935E97BOY8 openfda.unii unii ZAD9OKH9JC openfda.unii unii PQ6CK8PD0R openfda.unii unii 3A3U0GI71G openfda.unii unii 6SO6U10H04 openfda.unii unii AAN7QOV9EA openfda.unii unii P6YC3EG204 openfda.unii unii 1C4QK22F9J openfda.unii unii 68Y4CF58BV openfda.unii unii 1C6V77QF41 openfda.unii unii H4N855PNZ1 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.