L-METHYLFOLATE CALCIUM
-
levomefolate calcium tablet
Seton Pharmaceuticals
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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DuLeek™-Dp 15 is an orally administered prescription vitamin/medical food.
Each tablet contains the following Dietary Ingredient: Folate (as L-Methylfolate Calcium, or 6(S)-5-MTHF-Ca) . . . 15 mg
DuLeek™-Dp 15 is an orally administered prescription vitamin/medical food indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of dietary supplementation.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Folates (including folic acid and reduced folates), when administered as a single agent in doses above 0.1 mg daily, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.
DuLeek™-Dp 15 is a prescription vitamin/medical food for use only under medical supervision and direction.
Drugs which may interact with folate include:
Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates – including reduced folates.
Usual dose is one 15 mg tablet per day with or without food or as directed by a physician.
DuLeek™-Dp 15 is supplied as oval, blue tablets with “T505” debossed on one side.
Commercial Product:
Bottle of 90 tablets - 13925-143-901
Store at controlled room temperature 15°-30°C (59° to 86°F). [See USP]. Protect from light and moisture. Dispense in original light-resistant container.
Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Rx Only
Reserved for Professional Recommendation
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.
Manufactured For:
Seton Pharmaceuticals
Manasquan, NJ 08736
1-800-510-3401
MADE IN CANADA
05/10
SETON
PHARMACEUTICALS
NDC 13925-143-90*
DuLeekTM- Dp 15
Tablets
Rx Only
90 Tablets
SETON
PHARMACEUTICALS
L-METHYLFOLATE CALCIUM
levomefolate calcium tablet |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
UNAPPROVED DRUG OTHER | 06/30/2010 | 03/17/2012 |
Labeler - Seton Pharmaceuticals (828898002) |
Registrant - Seton Pharmaceuticals (828898002) |
Establishment | |||
Name | Address | ID/FEI | Operations |
VIVA | 253288898 | MANUFACTURE |
Establishment | |||
Name | Address | ID/FEI | Operations |
Rainbow Gold | 800695152 | REPACK |
Revised: 08/2012 Seton Pharmaceuticals