Label: FOLTREXYL- folic acid, vitamin d3 tablet
- NDC Code(s): 59088-447-54
- Packager: PureTek Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated October 29, 2020
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Foltrexyl™ is an orally administered prescription folate product for the dietary management of patients with unique
nutritional needs requiring increased folate levels and Vitamin D supplementation due to Vitamin D deficiency.
Foltrexyl™ should be administered under the supervision of
a licensed medical practitioner.
Each tablet contains:
Folate (as folic acid)……………………..1700 mcg DFE†
(1000 mcg folic acid)
Vitamin D3 (cholecalciferol)………....125 mcg (5000 IU)
Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium
starch glycolate, stearic acid, magnesium stearate.
† Dietary Folate Equivalent
- INDICATIONS AND DOSAGE
The in vivo synthesis of the major biologically active metabolites of vitamin D occurs in two steps. The first hydroxylation of ergocalciferol takes place in the liver (to 25-hydroxyvitamin D) and the second in the kidneys (to 1,25-dihydroxyvitamin D). Vitamin D metabolites promote the active absorption of calcium and phosphorus by the small intestine, thus elevating serum calcium and phosphate levels sufficiently to permit bone mineralization. Vitamin D metabolites also mobilize calcium and phosphate from bone and probably increase the reabsorption of calcium and perhaps also of phosphate by the renal tubules.
There is a time lag of 10 to 24 hours between the administration of vitamin D and the initiation of its action in the body due to the necessity of synthesis of the active metabolites in the liver and kidneys. Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys.
WARNINGS AND PRECAUTIONS
Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
Foltrexyl™ Tablets are supplied as round, light yellow tablets with one side scored, the other side plain and dispensed in child-resistant bottles of 30 tablets (NDC 59088-447-54*).
* This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels (AUG 2, 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) or similarly-formatted product code, as required by pedigree reporting requirements and supply-chain control as well as in some cases, for insurance-reimbursement applications. 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.
KEEP OUT OF THE REACH OF CHILDREN.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Protect from heat, light and moisture.
Tamper Evident: Do not use if seal is broken or missing
Manufactured in the USA by:
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873
- PACKAGE LABEL / PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
folic acid, vitamin d3 tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59088-447 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg VITAMIN D (UNII: 9VU1KI44GP) (CHOLECALCIFEROL - UNII:1C6V77QF41) VITAMIN D 125 ug Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) MAGNESIUM STEARATE (UNII: 70097M6I30) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color yellow Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59088-447-54 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/29/2020 Labeler - PureTek Corporation (785961046) Establishment Name Address ID/FEI Business Operations PureTek Corporation 785961046 manufacture(59088-447)