Home FDA labels 57480a0e-f36b-8c8f-e063-6394a90a82da PRENATE Restore 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 PRENATE Restore
Generic name ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENT
Manufacturer Avion Pharmaceuticals, LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 1076ba9a-0168-492f-ba9b-99fa02186092
SPL ID 57480a0e-f36b-8c8f-e063-6394a90a82da
Version 7
Effective date 2026-07-23
Source export date 2026-10-12
Source partition 11
Source file https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:45:45 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 · 20 matching rows.
Type, Scope, Identifier table Type Scope Identifier Source field brand name PRENATE Restore openfda.brand_name generic name ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENT openfda.generic_name manufacturer name Avion Pharmaceuticals, LLC openfda.manufacturer_name ndc package 75854-308-30 openfda.package_ndc ndc product 75854-308 openfda.product_ndc ndc11 package 75854030830 derived:openfda.package_ndc spl id 57480a0e-f36b-8c8f-e063-6394a90a82da id spl set id 1076ba9a-0168-492f-ba9b-99fa02186092 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 P6YC3EG204 openfda.unii unii WR1WPI7EW8 openfda.unii unii 68Y4CF58BV openfda.unii unii 1C6V77QF41 openfda.unii unii 33X04XA5AT 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.
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 KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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.