Accentrate PNV
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
- Accentrate PNV
- Generic name
- PRENATAL MULTIVITAMIN TABLET AND COMBINATION OMEGA-3 SOFTGEL/MINERAL CAPSULE
- Manufacturer
- Key Therapeutics
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 3008e7e0-01d9-bc7c-e063-6394a90a5247
- SPL ID
- 30099839-9f77-952c-e063-6294a90a2a1c
- Version
- 2
- Effective date
- 2025-03-10
- Source export date
- 2026-09-28
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:12:41
| 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 | Accentrate PNV | openfda.brand_name | |
| generic name | PRENATAL MULTIVITAMIN TABLET AND COMBINATION OMEGA-3 SOFTGEL/MINERAL CAPSULE | openfda.generic_name | |
| manufacturer name | Key Therapeutics | openfda.manufacturer_name | |
| ndc | package | 70868-511-30 | openfda.package_ndc |
| ndc | package | 70868-510-30 | openfda.package_ndc |
| ndc | package | 70868-513-30 | openfda.package_ndc |
| ndc | package | 70868-512-30 | openfda.package_ndc |
| ndc | product | 70868-510 | openfda.product_ndc |
| ndc11 | package | 70868051030 | derived:openfda.package_ndc |
| ndc11 | package | 70868051130 | derived:openfda.package_ndc |
| ndc11 | package | 70868051230 | derived:openfda.package_ndc |
| ndc11 | package | 70868051330 | derived:openfda.package_ndc |
| spl id | 30099839-9f77-952c-e063-6294a90a2a1c | id | |
| spl set id | 3008e7e0-01d9-bc7c-e063-6394a90a5247 | set_id |
Boxed warning 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 a Poison Control Center immediately .
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings and cautions
WARNINGS/PRECAUTIONS: Caution is recommended in patients with a family history of bipolar illness. Mood elevation is possible in this population. Caution is also recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, it has been reported that anticonvulsant medications interfere with folate metabolism, but the exact action is unclear; therefore caution is recommended with patients in this therapeutic group. Patients undergoing cancer treatment should consult their licensed medical practitioner for advice. Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations progress. Daily ingestion of more than 3 grams per day of omega-3 fatty acids (DHA, ALA, and EPA) may have potential antithrombotic activities, or effects, and may increase bleeding times. Administration of omega-3 fatty acids, including DHA, should be avoided in patients with inherited or acquired bleeding diathesis, including those taking anticoagulants. Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Allergic reactions have been reported following the use of oral and parenteral folate. xxix Mild transient diarrhea, polycythemia vera, itching, transitory exanthema, and the feeling of swelling of the entire body have been associated with methylcobalamin. xxx Allergic reactions, acne, skin reactions, photosensitivity, nausea, vomiting, abdominal pain, loss of appetite, paresthesia, somnolence, nausea, and headaches have been associated with pyridoxal-5’-phosphate. xxxi Call your medical practitioner about side effects. You may report side effects to the FDA at 1-800- FDA-1088 or call Key Therapeutics, LLC. at 888-981-8337.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.