Integra F
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
- Integra F
- Generic name
- FERROUS FUMARATE AND POLYSACCHRIDE IRON COMPLEX AND FOLIC ACID
- Manufacturer
- U.S. Pharmaceutical Corporation
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 025fee85-53a8-4161-a806-44fd95d0ca74
- SPL ID
- 7aa8c3c6-7a91-4217-9e48-e1dfcf938060
- Version
- 5
- Effective date
- 2022-11-08
- 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 06:28:02
| 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 | Integra F | openfda.brand_name | |
| generic name | FERROUS FUMARATE AND POLYSACCHRIDE IRON COMPLEX AND FOLIC ACID | openfda.generic_name | |
| manufacturer name | U.S. Pharmaceutical Corporation | openfda.manufacturer_name | |
| ndc | package | 52747-711-30 | openfda.package_ndc |
| ndc | package | 52747-711-60 | openfda.package_ndc |
| ndc | product | 52747-711 | openfda.product_ndc |
| ndc11 | package | 52747071160 | derived:openfda.package_ndc |
| ndc11 | package | 52747071130 | derived:openfda.package_ndc |
| rxcui | 999826 | openfda.rxcui | |
| rxcui | 999823 | openfda.rxcui | |
| spl id | 7aa8c3c6-7a91-4217-9e48-e1dfcf938060 | id | |
| spl set id | 025fee85-53a8-4161-a806-44fd95d0ca74 | set_id | |
| unii | R5L488RY0Q | openfda.unii | |
| unii | 2679MF687A | openfda.unii | |
| unii | H7426RGB3L | openfda.unii | |
| unii | 935E97BOY8 | openfda.unii | |
| unii | PQ6CK8PD0R | 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. WARNING: Folic acid alone is improper therapy in the treatment for pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. PRECAUTIONS: General: Anemia is a manifestation that requires appropriate investigation to determine its cause or causes. No single regimen fits all cases and the status of the patient observed in follow-up is the final criterion for adequacy of therapy. Periodic clinical and laboratory studies are considered essential. Blood examinations including hemoglobin and hematacrit should be done at the usual intervals to make certain that therapy is adequate. Use with care in the presence of peptic ulcer, regional enteritis, and ulcerative colitis. Folic acid, especially in doses above 0.1 mg -0.4 mg daily may obscure pernicious anemia, in that hematological remission can occur while neurological manifestations remain progressive.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse Reactions: Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation, heartburn and vomiting) occur occasionally, but are usually mild and may subside with continuation of therapy. Reducing the dose and administering it with meals will minimize these effects in the sensitive patient. Increasing fiber in the diet can relieve constipation. Iron may turn stools black. This is a harmless effect that is a result of unabsorbed iron. Although the absorption of iron is best when taken between meals, giving Integra FTM after meals may control occasional G.I. disturbances. Integra FTM is best absorbed when taken at bedtime.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.