Folixate
Generic Formulation: FOLATE, VITAMIN D3
Regulatory Registrant: PureTek Corporation
Related NDC Products
| NDC Code | Dosage Form | Route | Category |
|---|---|---|---|
| 59088-301 | TABLET | ORAL | UNAPPROVED DRUG OTHER |
Indications & Usage
INDICATIONS AND USAGE Folixate ™ is indicated for dietary management of patients with unique nutritional needs requiring increased folate level and Vitamin D supplementation. Folixate™ can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers.
Dosage & Administration
DOSAGE AND ADMINISTRATION Take one tablet daily or as directed by a licensed healthcare practitioner.
Warnings & Precautions
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. Folate alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folate in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Side Effects
ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folate. You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact PureTek Corporation, at 1-877-921-7873.
Storage & Handling
STORAGE KEEP THIS AND ALL MEDICATIONS 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.