Dosage and administration
Usual adult dose is one to two tablets daily or as directed by your medical practitioner. L-Methyl-MC Tablets is not recommended for use with children under the age of twelve.
L-Methyl-MC Tablets
- Manufacturer
- Virtus Pharmaceuticals
- Effective date
- 2015-09-17
- Label type
- MEDICAL FOOD
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:48:06
Label at a glance#
ProductL-Methyl-MC
Active ingredientLevomefolate Calcium, Riboflavin, Pyridoxine Hydrochloride, Cyanocobalamin
Label structure14 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
A medical food for the dietary management of hyperhomocysteinemia.
Description
Each round coated blue colored tablet contains:
| Dietary Ingredients: | |
|---|---|
| L-methylfolate Calcium | 6 mg |
| Riboflavin | 5 mg |
| Pyridoxine (as Pyridoxine HCl) | 50 mg |
| Cyanocobalamin | 1 mg |
Ingredients
Microcrystalline Cellulose, Pyridoxine HCl,Opadry II Blue #40L10890 (Polydextrose, Hypromellose HPMC 2910, FD&C Blue #1 Aluminum Lake, Triacetin, Titanium Dioxide, Peg 8000). Stearic Acid (Vegetable Source), Croscarmellose Sodium, L-methylfolate Calcium, Riboflavin, Silicon Dioxide, Magnesium Stearate (Vegetable Source), Opadry II Clear #Y-19-7483, (Hypromellose HPMC 2910, Maltodextrin, Peg 400), Cyanocobalamin.
L-Methyl-MC Tablets do not contain sugar, lactose, yeast or gluten.
Indication and Usage
L-Methyl-MC Tablets are indicated for the distinct nutritional requirements of individuals under medical supervision for hyperhomocysteinemia; with particular emphasis for individuals diagnosed with or at risk for mild to moderate: cognitive impairment1, vascular dementia2, or Alzheimer's disease3.
Precautions
Folates, when administered as a single agent in doses above 0.1mg daily, may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 1 mg of cyanocobalamin contained in L-Methyl-MC Tablets has been shown to provide an adequate amount of cyanocobalamin to address this precaution4. A safe upper limit of 100 mg per day has been established for the unsupervised medical use of pyridoxine. Consider all sources of pyridoxine supplementation when prescribing L-Methyl-MC Tablets.
Adverse Reactions
While allergic sensitization has been reported following both oral and parenteral administration of folic acid, allergic sensitization has not been reported with the use of L-Methylfolate Calcium. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cyanocobalamin. Transient headaches have been reported infrequently with the use of L-Methyl-MC Tablets. If headaches should occur with the use of L-Methyl-MC Tablets consult with your medical practitioner.
Contraindications
Known hypersensitivity to any of the components in the product is a contraindication.
Drug Interactions
L-Methyl-MC Tablets added to other drugs
High dose folic acid may result in decreased serum levels for pyrimethamine and first-generation anticonvulsants (carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone, valproic acid, valproate). This may possibly reduce first generation anticonvulsants effectiveness and/or increasing the frequency of seizures in susceptible patients. While the concurrent use of folic acid and first generation anticonvulsants or pyrimethamine may result in decreased efficacy of anticonvulsants, no such decreased effectiveness has been reported with the use of L-methylfolate. Nevertheless, caution should be used when prescribing L-METHYL-MC TABLETS among patients who are receiving treatment with first generation anticonvulsants or pyrimethamine. Pyridoxine should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine. However, pyridoxine may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Capecitabine (Xeloda®) toxicity may increase with the addition of leucovorin (5-formyltetrahydrofolate) (folate).
Drugs added to L-METHYL-MC TABLETS
Antibiotics may alter the intestinal microflora and may decrease the absorption of cyanocobalamin. Cholestyramine, colchicines or colestipol may decrease the enterohepatic reabsorption of cyanocobalamin. Metformin, para-aminosalicylic acid and potassium chloride may decrease the absorption of cyanocobalamin. Nitrous oxide can produce a functional cyanocobalamin deficiency. Several drugs are associated with lowering serum folate levels or reducing the amount of active folate available. First generation anticonvulsants (carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone, valproic acid, valproate) and lamotrigine (a second-generation anticonvulsant) may decrease folate plasma levels. Information on other second-generation anticonvulsants impact on folate levels is limited and cannot be ruled out. Methotrexate, alcohol (in excess), sulfasalazine, cholestyramine, colchicine, colestipol, L-dopa, methylprednisone, NSAIDs (high dose), pancreatic enzymes (pancrelipase, pancratin), pentamidine, pyrimethamine, smoking, triamterene, and trimethoprim may decrease folate plasma levels. Warfarin can produce significant impairment in folate status after a 6 month therapy.
Patient Information
L-Methyl-MC Tablets is a medical food for use only under medical supervision.
Dosage and Administration
Usual adult dose is one to two tablets daily or as directed by your medical practitioner. L-Methyl-MC Tablets is not recommended for use with children under the age of twelve.
How Supplied
Available as a round coated blue colored tablet. Debossed with "V360" on one side and blank on the other. Commercial product is supplied in bottles of 90 tablets (76439-360-901). Use under medical/physician supervision.
1 Virtus Pharmaceuticals, LLC does not represent this product code to be a National Drug Code (NDC) number. Instead, Virtus Pharmaceuticals, LLC has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and health insurance computer systems.
Storage
Store at controlled room temperature 15ºC to 30ºC (59ºF to 86ºF) (See USP).
Patents
Some or all of the following-patents may apply:
U.S. Patent No. 5,563,126
U.S. Patent No. 5,795,873
U.S. Patent No. 5,997,915
U.S. Patent No. 6,011,040
U.S. Patent No. 6,207,651
U.S. Patent No. 6,254,904
U.S. Patent No. 6,297,224
U.S. Patent No. 6,528,496
and other pending patent applications.
References
1 Lehmann M, Regland B, Blennow K, and Gottfries CG: Vitamin B12-B6-Folate Treatment Improves Blood-Brain Barrier Function in Patients with Hyperhomocysteinaemia and Mild Cognitive Impairment. Dementia and Geriatric Cognitive Disorders 2003;16:145-150.
2 Nilsson K, Gustafson L, and Hultberg B: Improvement of cognitive functions after cobalamin/folate supplementation in elderly patients with dementia and elevated plasma homocysteine. International Journal of Geriatric Psychiatry 2001;16:609-614.
3 Seshadri S, Beiser A, Selhub J, Jacques PF, Rosenberg IH, D'Agostino RB, Wilson PWF, and Wolf PA: Plasma Homocysteine As A Risk Factor For Dementia And Alzheimer's Disease. New England Journal of Medicine 2002:Vol346, No. 7:476-483.
4 Lederle FA: Oral cobalamin for pernicious anaemia: medicine's best kept secret. JAMA 1991;265:94-95.
SPL UNCLASSIFIED SECTION
Manufactured for:
Virtus Pharmaceuticals, LLC
Tampa, FL 33619
PC0296-00
Revised 11/14
PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label
VIRTUS
PHARMACEUTICALS
76439-360-90
L-METHYL-MC
TABLETS
RX
90 Tablets
Made in the USA
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CYANOCOBALAMIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| LEVOMEFOLIC ACID Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20230428 |
| PYRIDOXINE Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20170310 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| b82b4008-22fd-05f5-6cc6-c0a6e81c65b8 | Product name | 2 | 20240805 |
| ddff2484-d547-4e6a-bacd-95eef7e31c64 | Product name | 2 | 20180807 |
| 90854981-3820-4bc4-a1d3-666ec508941c | Product name | 2 | 20180214 |
| d206bb34-ea65-399d-70d9-834f22dc2c18 | Product name | 3 | 20170724 |
| 5e18e798-5614-cf5c-0185-38b1cb77a093 | Product name | 2 | 20160822 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76439-360-90 | L-Methyl-MC | 90 in 1 BOTTLE | TABLET, COATED | 90 | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76439-360-90 | EA - Each | 76439-360 | 6b5b7b99-82a1-4e30-861e-b826b369d136 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Cyanocobalamin | ACTIVE INGREDIENT | P6YC3EG204 | 3 | |
| Levomefolate Calcium | ACTIVE INGREDIENT | A9R10K3F2F | 3 | |
| Pyridoxine Hydrochloride | ACTIVE INGREDIENT | 68Y4CF58BV | 3 | |
| Riboflavin | ACTIVE INGREDIENT | TLM2976OFR | 3 | |
| Cyanocobalamin | ACTIVE MOIETY | P6YC3EG204 | 3 | |
| Levomefolic Acid | ACTIVE MOIETY | 8S95DH25XC | 3 | |
| Pyridoxine | ACTIVE MOIETY | KV2JZ1BI6Z | 3 | |
| Riboflavin | ACTIVE MOIETY | TLM2976OFR | 3 | |
| Aluminum Oxide | INACTIVE INGREDIENT | LMI26O6933 | 3 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 3 | |
| Croscarmellose Sodium | INACTIVE INGREDIENT | M28OL1HH48 | 3 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 3 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | 3 | |
| Maltodextrin | INACTIVE INGREDIENT | 7CVR7L4A2D | 3 | |
| Polydextrose | INACTIVE INGREDIENT | VH2XOU12IE | 3 | |
| Polyethylene Glycol 400 | INACTIVE INGREDIENT | B697894SGQ | 3 | |
| Polyethylene Glycol 8000 | INACTIVE INGREDIENT | Q662QK8M3B | 3 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 3 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 3 | |
| Triacetin | INACTIVE INGREDIENT | XHX3C3X673 | 3 |
Products#
Every source-derived product name is available through these pages.
- L-Methyl-MC
- Levomefolate Calcium, Riboflavin, Pyridoxine Hydrochloride, and Cyanocobalamin
- Levomefolate Calcium
- Levomefolic Acid
- Riboflavin
- Pyridoxine Hydrochloride
- Pyridoxine
- Cyanocobalamin
- Cellulose, Microcrystalline
- Polydextrose
- FD&C Blue No. 1
- Aluminum Oxide
- Triacetin
- Titanium Dioxide
- Polyethylene Glycol 8000
- Stearic Acid
- Croscarmellose Sodium
- Silicon Dioxide
- Magnesium Stearate
- Maltodextrin
- Polyethylene Glycol 400
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76439-360 | 76439-360-90 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, DELAYED RELEASE / ORAL | 26 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TROCHE / ORAL | 300 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, COATED PELLETS / ORAL | 198 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, ORALLY DISINTEGRATING / ORAL | 184 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| Polyethylene Glycol 8000 | POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | TABLET / ORAL | 1200 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FOR SUSPENSION / ORAL | 20100 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| Polyethylene Glycol 8000 | POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 14 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION/ DROPS / OPHTHALMIC | 1 %w/v | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, SUGAR COATED / ORAL | NA | ||
| Aluminum Oxide | ALUMINUM OXIDE | LMI26O6933 | SPONGE / TOPICAL | NA | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, EXTENDED RELEASE / ORAL | 1246 mg | ||
| Triacetin | TRIACETIN | XHX3C3X673 | CAPSULE, DELAYED RELEASE / ORAL | 5.1 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| Maltodextrin | MALTODEXTRIN | 7CVR7L4A2D | LOZENGE / ORAL | 175 mg | ||
| Polydextrose | POLYDEXTROSE | VH2XOU12IE | TABLET / ORAL | 20 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| Magnesium Stearate | MAGNESIUM STEARATE | 70097M6I30 | RING / VAGINAL | 2 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE / ORAL | 150 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| Polyethylene Glycol 8000 | POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, EXTENDED RELEASE / ORAL | 60 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| Triacetin | TRIACETIN | XHX3C3X673 | TABLET, COATED / ORAL | 1 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CREAM / VAGINAL | 51 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | SUSPENSION / ORAL | 150 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | CAPSULE, DELAYED RELEASE / ORAL | 366 mg | ||
| Triacetin | TRIACETIN | XHX3C3X673 | SUSPENSION, EXTENDED RELEASE / ORAL | 4 mg | ||
| Polyethylene Glycol 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | OINTMENT / TOPICAL | 1950 mg | ||
| Croscarmellose Sodium | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / SUBLINGUAL | 10 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| FD&C Blue No. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.