choices DermacinRx PureFolix Generic Name: folic acid, vitamin d3 Dosage Form: tablet Print this page 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. DermacinRx PureFolix Description PureFolix 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. PureFolix should be administered under the supervision of a licensed medical practitioner. Each tablet contains: Folic Acid ..........................................................................1 mg Vitamin D 3 (cholecalciferol) ......................................5000 IU Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, stearic acid, magnesium stearate. INDICATIONS AND DOSAGE PureFolix is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels and Vitamin D supplementation. PureFolix can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers. DermacinRx PureFolix - Clinical Pharmacology 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. Contraindications This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. PureFolix is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D. Warnings and Precautions KEEP OUT OF THE REACH OF CHILDREN. 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 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 PureTek Corporation, at 1-877-921-7873. DermacinRx PureFolix Dosage and Administration Take one tablet daily or as directed by a healthcare practitioner. How is DermacinRx PureFolix Supplied PureFolix Tablets are supplied as round, light yellow tablets printed with one side scored, the other side plain and dispensed in child-resistant bottles of 30 tablets (NDC 59088-090-54*). * 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 STORAGE 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: PureTek Corporation San Fernando, CA 91340 For questions or information call toll-free: 877-921-7873 Visit: dermacinrx.com Rev. 29355 10/15 PACKAGE LABEL / PRINCIPAL DISPLAY PANEL Bottle Label (30 Tablets) DermacinRx PureFolix folic acid, vitamin d3 tablet Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59088-090 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg VITAMIN D (CHOLECALCIFEROL) VITAMIN D 125 ug Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE LACTOSE MONOHYDRATE SODIUM STARCH GLYCOLATE TYPE A CORN MAGNESIUM STEARATE STEARIC ACID Product Characteristics Color yellow Score 2 pieces Shape ROUND Size 8mm Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:59088-090-54 30 TABLET in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/03/2015 Labeler - PureTek Corporation (785961046) Establishment Name Address ID/FEI Operations PureTek Corporation 785961046 manufacture(59088-090) Revised: 11/2015 PureTek Corporation FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... 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take-heed call DermacinRx PureFolix to collapse
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