DENOVO- levomefolic acid capsule 
Magna Pharmaceuticals, Inc.

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Denovo

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

DENOVO 
levomefolic acid capsule
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:58407-150
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID15 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
WATER (UNII: 059QF0KO0R)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:58407-150-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
dietary supplement09/15/2020
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
shape
size (solid drugs)20 mm
scoring1
Labeler - Magna Pharmaceuticals, Inc. (620988360)
Registrant - Magna Pharmaceuticals, Inc. (620988360)
Establishment
NameAddressID/FEIBusiness Operations
Magna Pharmaceuticals, Inc.620988360label(58407-150)

Revised: 9/2020
Document Id: 39b2194a-8656-41ae-adcd-14046327a57b
Set id: 26d325be-ea7f-4543-b5e8-a1212cbec36d
Version: 1
Effective Time: 20200922
 
Magna Pharmaceuticals, Inc.