{"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual adult dose is one (1) tablet once or twice daily or as prescribed by a licensed medical practitioner.*"],"effective_time":"20200210","how_supplied":["Folinex™ capsules are supplied as a solid, opaque, white, oblong capsule with “916” printed on one side, dispensed in child-resistant bottles of 30ct (72380-916-30*)."],"id":"92d760e5-4d0f-4a7a-80f4-16507c125711","openfda":{},"other_safety_information":["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. Do not use if seal is broken or missing.","* 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."],"package_label_principal_display_panel":["Package Label NDC# 72380-916-30 VIVERA™ PHARMACEUTICALS Folinex™ 30 Capsules Dispensed by Prescription Only Supplement Facts Serving Size: 1 Capsule Servings per container: 30 Amount Per Serving %Daily Value Vitamin C 500 mg 555% (Ascorbic Acid) Vitamin B12 1 mg 41,666% (as Methylcobalamin) Vitamin K MK7 100 mcg 83% Folate 1700 mcg DFE 425% (1 mg Folic Acid) Other ingredients: Gelatin, Magnesium Stearate, Microcrystalline Cellulose, Dicalcium Phosphate, Silicon Dioxide, Titanium Dioxide Dosage: Adult dose is one (1) capsule once or twice daily or as prescribed by a licensed medical practitioner. If you are pregnant or nursing, ask a healthcare professional. KEEP OUT OF REACH OF CHILDREN STORAGE: Store at 20°-25°C (68°-77°F); excusions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.] Protect from heat, light , and moisture Manufactured for: Vivera Pharmaceuticals, Inc. 11100 Greenstone Ave. Santa Fe Springs, CA 90670 MADE IN THE U.S.A. REV120519 LOT NO: EXP. DATE: MFG. DATE: 3 72389 00004 9 RES Folinex"],"precautions":["PRECAUTIONS Tell your doctor if you have: kidney problems or 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."],"pregnancy":["If you are pregnant or nursing, ask a healthcare professional."],"set_id":"a63b92a5-32a5-4c73-8bf7-cb8b7bc2bf2d","spl_product_data_elements":["Folinex VITAMIN C, VITAMIN B12, VITAMIN K MK7, FOLATE ASCORBIC ACID ASCORBIC ACID METHYLCOBALAMIN METHYLCOBALAMIN VITAMIN K7 VITAMIN K7 FOLIC ACID FOLIC ACID GELATIN MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE ANHYDROUS DIBASIC CALCIUM PHOSPHATE SILICON DIOXIDE TITANIUM DIOXIDE 916"],"spl_unclassified_section":["FACTS Folinex™ is an orally administered prescription folate product for the dietary management of patients with unique nutritional needs requiring increased folate levels and other nutritional supplementation. Folinex™ should be administered under the supervision of a licensed medical practitioner. Folinex™ is used for dietary management of patients with unique nutritional needs requiring increased folate levels, or are in need of other nutritional supplementation. Folinex™ can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers under the supervision of a licensed medical practitioner."],"version":"2","warnings":["WARNINGS 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."]}