{"adverse_reactions":["ADVERSE REACTIONS: Allergic reactions have been reported following the use of oral and parenteral vitamin B 9 . Call your medical practitioner about side effects."],"contraindications":["CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product."],"description":["DESCRIPTION: Levomefolate Calcium/Algal Powder (15 mg-90.314 mg) is an orally administered prescription dietary supplement, and should be administered under the supervision of a licensed medical practitioner. INGREDIENTS: Each capsule contains the following dietary ingredients: L-Methylfolate Calcium CAS #151533-22-1 15 mg Algae Powder (schizochytrium) 90.314 mg Other Ingredients: Silicified Microcrystalline Cellulose, Gelatin (Kosher [Ko]), Magnesium Stearate (Vegetable Source), Titanium dioxide [color], FD&C Yellow #6 [color], FD&C Red #40 [color], Propylene Glycol, Povidone, Sodium Hydroxide, Shellac."],"description_table":["
L-Methylfolate Calcium CAS #151533-22-1 15 mg
Algae Powder (schizochytrium) 90.314 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Usual adult dose is one capsule daily with or without food or as directed by a licensed medical practitioner. Store at controlled room temperature 15°-30°C (59°-86°F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container. Notice: Contact with moisture may produce surface discoloration or erosion. Call your medical practitioner about side effects. You may report side effects by calling 813-283-1344."],"effective_time":"20150505","how_supplied":["HOW SUPPLIED: Levomefolate Calcium/Algal Powder (15 mg-90.314 mg) is supplied as orange capsule with imprint \"ME15\", dispensed in bottles of 90 capsules. † This product is a prescription-vitamin B 9 with or without other dietary ingredients that - due to increased vitamin B9 levels (AUG 2 1973 FR 20750), requires an R x on the label because of increased risk associated with masking of B 12 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 similar product code, as required by pedigree reporting requirements and supply-chain control as well as - in some cases, for insurance-reimbursement applications."],"id":"e92279ea-513e-4835-ad8b-1001cb17c2bf","indications_and_usage":["INDICATIONS AND USAGE: Levomefolate Calcium/Algal Powder (15 mg-90.314 mg) is indicated for the distinct nutritional requirements of patients in need of advanced vitamin B 9 supplementation-specifically suboptimal vitamin B 9 or maintenance-level needs, as determined by a licensed medical practitioner."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 90 Capsule Bottle Label VIRTUS PHARMACEUTICALS 76439- 322 -90 † Levomefolate Calcium/ Alga Powder (15 mg-90.314 mg) Prescription Vitamin B 9 -Containing Dietary Supplement R x 90 Capsules Made in the USA 90 capsulebottle Label"],"precautions":["PRECAUTIONS: Vitamin B 9 alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Vitamin B 9 in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations progress."],"pregnancy":["PREGNANCY and NURSING MOTHERS: This product is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers. This product contains B vitamins plus Algal. Talk with your medical practitioner before using if pregnant or lactating."],"references":["REFERENCES: Federal Register Notice of April 9, 1971 (36 FR 6843). The Federal Register Notice of August 2, 1973 (38 FR 20750). The Federal Register Notice of October 17, 1980 (45 FR 69044). Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B 6 , and Vitamin B 12 and Vascular Disease (Docket No. 99P-3029). November 28, 2000. The Federal Register Notice of March 5, 1996 (61 FR 8760). Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects (Docket No. 91N-100H). October 10, 2000. Code of Federal Regulations Title 21 Section 172.345. Code of Federal Regulations Title 21 Section 101.9(j)(8)."],"references_table":["
Federal Register Notice of April 9, 1971 (36 FR 6843).
The Federal Register Notice of August 2, 1973 (38 FR 20750).
The Federal Register Notice of October 17, 1980 (45 FR 69044).
Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin
B6, and Vitamin B12 and Vascular Disease (Docket No. 99P-3029). November 28, 2000.
The Federal Register Notice of March 5, 1996 (61 FR 8760).
Letter Regarding Dietary Supplement Health Claim for Folic Acid With Respect to Neural Tube Defects (Docket No. 91N-100H). October 10, 2000.
Code of Federal Regulations Title 21 Section 172.345.
Code of Federal Regulations Title 21 Section 101.9(j)(8).
"],"set_id":"81292445-7c41-4c3e-93cb-5b0ef280da56","spl_product_data_elements":["levomefolate calcium and schizochytrium dha Levomefolate Calcium and Algal Powder LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID SCHIZOCHYTRIUM DHA OIL SCHIZOCHYTRIUM DHA OIL CELLULOSE, MICROCRYSTALLINE GELATIN MAGNESIUM STEARATE TITANIUM DIOXIDE FD&C YELLOW NO. 6 FD&C RED NO. 40 PROPYLENE GLYCOL POVIDONES SODIUM HYDROXIDE SHELLAC ME15"],"spl_unclassified_section":["Prescription Vitamin B 9 -Containing Dietary Supplement R x 90 Capsules","If you are pregnant or nursing a baby, please ask a health professional. KEEP THIS OUT OF REACH OF CHILDREN. This product is not recommended for use in children under the age of twelve. All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.","VITAMIN B 9 REGULATION: The Federal Register Notices from 1971 to 1973 established that increased vitamin B 9 was proper therapy in megaloblastic anemias of tropical and nontropical sprue, nutritional origin, pregnancy, infancy and childhood. Vitamin B 9 metabolism can be affected by malabsorption issues which differ widely among population groups. The March 5, 1996 Federal Register Notice (61 FR 8760) states that \"The agency concluded that the scientific literature did not support the superiority of any one source of vitamin B 9 over others, and that the data were insufficient to provide a basis for stating that a specific amount of vitamin B 9 is more effective than another amount [emphasis added].\" The actual amount and source of vitamin B 9 require a licensed medical practitioner's supervision to achieve a satisfactory maintenance level, and may exceed the 0.8 mg UL. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that \"dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription. Oral preparations supplying more than 0.8 mg of vitamin B 9 per dosage unit would be restricted to prescription dispensing and that a dietary supplement furnishing 0.8 mg could be prescribed when a maintenance level of 0.8 mg per day was indicated. When clinical symptoms have subsided and the blood picture and/or CSF vitamin B 9 levels have become normal, a maintenance level should be used. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent. In the presence of alcoholism, hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased [emphasis added].\" However, once the level of active vitamin B 9 exceeds 0.8 mg - as prescribed dosages, then the product is no longer a medical food but a dietary management / prescription (R x )-vitamin B 9 regardless of pregnancy/lactation status in spite of the fact that folic acid - including reduced forms, may be added to medical foods as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345). In the Letter Regarding Dietary Supplement Health Claim for Folic Acid, Vitamin B 6 , and Vitamin B 12 and Vascular Disease (Docket No. 99P-3029) dated November 28, 2000, FDA wrote \"... high intakes of vitamin B 9 may partially and temporarily correct pernicious anemia while the neurological damage of vitamin B 12 deficiency progresses. IOM/NAS (1998) set the UL for all adults of 1 mg per day because of devastating and irreversible neurological consequences of vitamin B 12 deficiency, the data suggesting that pernicious anemia may develop at a younger age in some racial or ethnic groups, and the uncertainty about the extent of the occurrence of vitamin B 12 deficiency in younger age groups (IOM/NAS, 1998) [emphasis added].\" Summary: This product is a dietary management product that - due to advanced vitamin B 9 levels, requires administration under the care of a licensed medical practitioner, and the most appropriate way to do that is to provide the product as prescription for pedigree reporting and safety monitoring. The ingredients, indication or claims of this product are not to be construed to be drug claims.","VITAMIN B 9 MECHANISM OF ACTION: Vitamin B 9 is essential for the production of certain coenzymes in many metabolic systems such as purine and pyrimidine synthesis. It is also essential in the synthesis and maintenance of nucleoprotein in erythropoiesis. It also promotes white blood cell (WBC) and platelet production in vitamin B9-deficiency anemia. Vitamin B 9 is associated with methylation and transformylation biochemistry.","INTERACTIONS: Talk to your healthcare practitioner and/or pharmacist before taking or using any prescription or over-the-counter medicines or herbal/health supplements alongside this product.","Manufactured for: Virtus Pharmaceuticals, LLC Tampa, FL 33619 REV 5/2014"],"version":"2","warnings":["WARNINGS: Caution is recommended in patients with a history of bipolar illness. Mood elevation is possible in this population. Caution is also recommended in patients taking anticonvulsant medications as vitamin B 9 may interfere with anticonvulsant medication, and may lower seizure threshold. Patients undergoing cancer treatment should consult their licensed medical practitioner for advice."]}