Finazol
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
- Brand name
- Finazol
- Generic name
- FERROUS FUMARATE, FOLATE
- Manufacturer
- PureTek Corporation
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 24290823-022a-433b-e063-6394a90a8fd0
- SPL ID
- 2657fc47-d75d-ff7d-e063-6394a90a68ee
- Version
- 2
- Effective date
- 2024-11-07
- Source export date
- 2026-09-28
- Source partition
- 14
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:40:55
| 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.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| brand name | Finazol | openfda.brand_name | |
| generic name | FERROUS FUMARATE, FOLATE | openfda.generic_name | |
| manufacturer name | PureTek Corporation | openfda.manufacturer_name | |
| ndc | package | 59088-008-54 | openfda.package_ndc |
| ndc | product | 59088-008 | openfda.product_ndc |
| ndc11 | package | 59088000854 | derived:openfda.package_ndc |
| spl id | 2657fc47-d75d-ff7d-e063-6394a90a68ee | id | |
| spl set id | 24290823-022a-433b-e063-6394a90a8fd0 | set_id | |
| unii | BR1SN1JS2W | openfda.unii | |
| unii | 19F5HK2737 | openfda.unii | |
| unii | N9E3X5056Q | openfda.unii | |
| unii | T8BEA5064F | openfda.unii | |
| unii | 25X51I8RD4 | openfda.unii | |
| unii | 3LE3D9D6OY | openfda.unii | |
| unii | R5L488RY0Q | openfda.unii | |
| unii | TLM2976OFR | openfda.unii | |
| unii | H0G9379FGK | openfda.unii | |
| unii | W00LYS4T26 | openfda.unii | |
| unii | PQ6CK8PD0R | openfda.unii | |
| unii | A150AY412V | openfda.unii | |
| unii | 660YQ98I10 | openfda.unii | |
| unii | 3A3U0GI71G | openfda.unii | |
| unii | 81AH48963U | openfda.unii | |
| unii | A9R10K3F2F | openfda.unii | |
| unii | 6SO6U10H04 | openfda.unii | |
| unii | 1C4QK22F9J | openfda.unii | |
| unii | 8K0I04919X | openfda.unii | |
| unii | WR1WPI7EW8 | openfda.unii | |
| unii | 68Y4CF58BV | openfda.unii | |
| unii | K72I3DEX9B | openfda.unii | |
| unii | 1C6V77QF41 | openfda.unii | |
| unii | H6241UJ22B | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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. Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient. Precautions: Folate in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. There is a potential danger in administering folate to patients with undiagnosed anemia, since folate may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia. The patient’s medical conditions and consumption of other drugs, herbs, and / or supplements should be considered. For use on the order of a licensed healthcare practitioner. Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Drug Interactions: Finazol™ is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin or Clopidogrel). Adverse Reactions: Folate : Allergic sensitizations have been reported following both oral and parenteral administration of folate. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Finazol™ after meals may control occasional gastrointestinal disturbances. Finazol™ is best absorbed when taken at bedtime. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse Reactions: Folate : Allergic sensitizations have been reported following both oral and parenteral administration of folate. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Finazol™ after meals may control occasional gastrointestinal disturbances. Finazol™ is best absorbed when taken at bedtime. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.