Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TriStart DHA | ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT, AND ICOSAPENT | CarWin Pharmaceutical Associates, LLC | 92ccf7d4-4527-49f0-b890-1a11b5a10086 | 2024-01-09 | Boxed warning, Warnings, Adverse reactions |
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.
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Caution is recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, anticonvulsant medications may interfere with folate metabolism.
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact CarWin Pharmaceutical Associates, LLC at 1-985-288-5122
| Ingredient | Strength |
|---|---|
| ASCORBIC ACID | 15 [iU]/1 |
| CHOLECALCIFEROL | 55 mg/1 |
| .ALPHA.-TOCOPHEROL ACETATE, D- | 1000 [iU]/1 |
| THIAMINE HYDROCHLORIDE | 14 ug/1 |
| RIBOFLAVIN | 200 mg/1 |
| NIACIN | 400 ug/1 |
| PYRIDOXINE HYDROCHLORIDE | 15 mg/1 |
| LEVOMEFOLATE MAGNESIUM | 31 mg/1 |
| FOLIC ACID | 600 ug/1 |
| CYANOCOBALAMIN | 30 mg/1 |
| IRON PENTACARBONYL | 5 mg/1 |
| POTASSIUM IODIDE | 200 ug/1 |
| MAGNESIUM OXIDE | 35 mg/1 |
| DOCONEXENT | 1.8 mg/1 |
| ICOSAPENT | 1.3 mg/1 |
| Field | Values |
|---|---|
| Unii | PQ6CK8PD0R, 1C6V77QF41, A7E6112E4N, M572600E5P, TLM2976OFR, 2679MF687A, 68Y4CF58BV, 1VZZ62R081, 935E97BOY8, P6YC3EG204, 6WQ62TAQ6Z, 1C4QK22F9J, 3A3U0GI71G, ZAD9OKH9JC, AAN7QOV9EA |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 15370-250-30 | TriStart DHA | 30 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 30 | 3 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 15370-250-30 | EA - Each | 15370-250 | dc53b307-6bde-492d-a5e6-c381c2931a8a | 1 | 2015-07-20 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 15370-250 | TRISTART DHA (ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT, AND ICOSAPENT) CAPSULE, LIQUID FILLED [CARWIN PHARMACEUTICAL ASSOCIATES, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240112_92ccf7d4-4527-49f0-b890-1a11b5a10086.zip |
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 15370-250-30 | 15370025030 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (15370-250-30) | 2015-06-01 | 0000-00-00 | No | No | Current |