Denovo

Manufacturer
Magna Pharmaceuticals, Inc.
Effective date
2020-09-22
Label type
Dietary Supplement
Version
1
Source
full-release
Hydrated at
2026-06-01 02:49:44

Label at a glance#

ProductDenovo
Active ingredientLEVOMEFOLATE CALCIUM
Label structure5 sections

Label contents#

Full prescribing information#

Supplement Facts

Statement of Identity section

Serving Size: 1 capsule

Servings per Container: 30

Each capsule contains the following:

Folate [as 15,000mcg (as 15mg) DFE (dietary folate equivalents) L-5 MTHF (from L-5 methyltetrahydrofolate calcium salt)]

Other Ingredients: Microcrystalline cellulose, capsule (gelatin,titanium dioxide, FD&C yellow #5, FD&C yellow #6), vegetable magnesium stearate, and silica

Warning and Precautions

WARNINGS SECTION

Folic Acid, when administered in daily doses above 0.1mg may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). 5-MTHF may be less likely than foli acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of a B12 deficiency.

A major depressive episode may be the inital presentation of bipolar disorder. It is generally believed, although not established in controlled trials, that treating such an episode with an antidepressant alone may increase the likelihood of a precipitation of mixed/manic episode in patients at risk for bipolar disorder. Denovo is not an antidepressant. However, 5-MTHF has been shown to enhance antidepressant effects of known antidepressants. Caution is recommended in patients with a history of bipolar illness. Patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder since mood elevation in this population is possible.

Denovo should always be used under medical supervision.

Safe Handling

SAFE HANDLING WARNING SECTION

Before using this product, tell your doctor or pharmacist of all of the products you use. Keep a list of all our medications with you and share the list with your doctor and pharmacist. No decrease in effectiveness of drugs has been reported witht the use of Denovo.

Allergic reactions have not been reported following the use of oral (6S) -5-methyltetrahydrofolic acid, glucosamine salt.

Take One capsule daily as directed by a health care professional

Store at 15o-30°C (59°-86° F)

Protect from heat, light and moisture. Keep out of reach of children. Do not purchase if seal is broken.

Indication and Use

HEALTH CLAIM SECTION

Adjunctive use in mood disorders

Denovo is indicated for the distinct nutritional requirements for people who have suboptimal levels of L-methylfolate in cerebrospinal fluid, plasma, and/or red blood cells and have major depressive disorder (MDD), with particular emphasis as adjunctive support for individuals who are on antidepressant. Denovo is indicated regardless of MTHFR C6771 polymorphism genotype.

Principal Display Panel- Denovo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Denovo

Dietary Supplement

Principal Display Panel-DenovoPrincipal Display Panel-Denovo

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LEVOMEFOLIC ACID Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230428

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58407-150-30Denovo30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58407-150DENOVO (LEVOMEFOLIC ACID) CAPSULE [MAGNA PHARMACEUTICALS, INC.]11 package rows20200924_26d325be-ea7f-4543-b5e8-a1212cbec36d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58407-15058407-150-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.