Denovo: Package Insert and Label Information

DENOVO- levomefolate calcium capsule
Magna Pharmaceuticals, Inc.

Supplement Facts

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

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

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

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

Denovo

Dietary Supplement

Principal Display Panel-Denovo
(click image for full-size original)
DENOVO
levomefolic acid capsule
Product Information
Product Type Item Code (Source) NDC:58407-150
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMEFOLATE CALCIUM (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 15 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
WATER
MICROCRYSTALLINE CELLULOSE
TITANIUM DIOXIDE
MAGNESIUM STEARATE
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
Product Characteristics
Color yellow Score no score
Shape capsule Size 20mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58407-150-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
dietary supplement 09/15/2020
Labeler — Magna Pharmaceuticals, Inc. (620988360)
Registrant — Magna Pharmaceuticals, Inc. (620988360)
Establishment
Name Address ID/FEI Operations
Magna Pharmaceuticals, Inc. 620988360 label (58407-150)

Revised: 09/2020 Magna Pharmaceuticals, Inc.

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