Label: DENOVO- levomefolic acid capsule
- NHRIC Code(s): 58407-150-30
- Packager: Magna Pharmaceuticals, Inc.
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated September 22, 2020
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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.
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
INGREDIENTS AND APPEARANCE
levomefolic acid capsule
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:58407-150 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 15 mg Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:58407-150-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date dietary supplement 09/15/2020 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape size (solid drugs) 20 mm scoring 1 Labeler - Magna Pharmaceuticals, Inc. (620988360) Registrant - Magna Pharmaceuticals, Inc. (620988360) Establishment Name Address ID/FEI Business Operations Magna Pharmaceuticals, Inc. 620988360 label(58407-150)