| L-Methylfolate Calcium (as or 6(S)-5-MTHF-Ca)L-Methylfolate Calcium (Form: or 6(S)-5-MTHF-Ca) Note: contains less than 1% d-methylfolate | 15 mg | † |
| Pyridoxal 5-Phosphate | 35 mg | † |
| Methylcobalamin | 2 mg | † |
Other ingredients: Dicalcium Phosphate, Microcrystalline Cellulose, FD&C Blue #2, FD&C Red #40, Titanium Dioxide, Modified Cellulose, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Silicon Dioxide, Polyethylene Glycol, Food Glaze
% Daily Values for: Adults and children 4 or more years of age.
Where this label comes from
An original label of the NIH's Dietary Supplement Label Database, entered there on 25 October 2013, shown here as it was entered. The NIH's record
General information
- Product name
- L-Methyl-B6-B12
- Brand
- Virtus Pharmaceuticals
- Barcode (UPC)
- 3 76439 21890 4
- Net contents
- 90 Tablet(s)
- Market status
- On market
- DSLD ID
- 22190
Classification
- Supplement form
- Tablet or Pill
- Product type
- Other Combinations
- Claim types on the label
- Nutrient, All Other
- Intended for
- Adult (18 - 50 Years)
Label statements
Precautions: All Other: L-Methyl-B6-B12 should be administered under the supervision of a licensed medical practitioner.
FDA Statement of Identity: Prescription Dietary Supplement
FDA Statement of Identity: Rx
Directions: DOSAGE AND ADMINISTRATION: One tablet twice daily or as directed by a licensed medical practitioner.
Storage: Store at controlled room temperature 15(0)-30(0)C (59(0)-86(0)F). [See USP]. Protect from light and moisture.
Precautions: Pregnant or Nursing or Prescription Medications: If you are pregnant or nursing a baby, ask a health professional.
Precautions: Children: KEEP THIS OUT OF REACH OF CHILDREN.
Precautions: All Other: All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Precautions: All Other: Call your medical practitioner about side effects.
Precautions: Pregnant or Nursing or Prescription Medications: - Sulfasalazine: Inhibits the absorption and metabolism of folic acid. - Metformin treatment in patients with type 2 diabetes decreases serum folate. - Warfarin can produce significant impairment in folate status after a 6-month therapy. - Folinic acid may enhance the toxicity of fluorouracil. - Concurrent administration of chloramphenicol and folinic acid in folate-deficient patients may result in antagonism of the haematopoietic response to folate. - Caution should be exercised with the concomitant use of folinic acid and trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection as it is associated with increased rates of treatment failure and mortality in a placebo controlled study. Drugs which may interact with vitamin B12: - Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic acid, and potassium chloride may decrease the absorption of vitamin B12. - Nitrous oxide can produce a functional vitamin B12 deficiency. Drugs which interact with vitamin B6: - Vitamin B6 should not be given to patients receiving the drug levodopa because the action of levodopa is antagonized by vitamin B6. However, vitamin B6 may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
Precautions: Pregnant or Nursing or Prescription Medications: PREGNANCY and NURSING MOTHERS: L-Methyl-B6-B12 is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers. This product contains B vitamins in active form. Talk with your medical practitioner before using if pregnant or lactating.
Directions: INDICATIONS AND USAGE: L-Methyl-B6-B12 is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. L-Methyl-B6-B12 should be administered under the supervision of a licensed medical practitioner.
Precautions: Allergies: CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Precautions: All Other: WARNINGS: Caution is recommended in patients with a history of bipolar illness. PRECAUTIONS: General: Folate, when administered as a single agent in doses about 0.1 mg daily, may obscure the detection of vitamin 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). Folate therapy alone is inadequate for treatment of a vitamin B12 deficiency. PATIENT INFORMATION: L-Methyl-B6-B12 is a prescription dietary supplement to be used only under licensed medical supervision.
Precautions: Pregnant or Nursing or Prescription Medications: DRUG INTERACTIONS: Drugs which may interact with folate include: - Antiepileptic drugs (AED): The AED class including, but not limited to, phenytoin, carbamazepine, primidone, valproic acid, fosphenytoin, valproate, phenobarbital and lamotrigine have been shown to impair folate absorption and increase the metabolism of circulating folate. - Additionally, concurrent use of folic acid has been associated with enhanced phenytoin metabolism, lowering the level of the AED in the blood and allowing breakthrough seizures to occur. Caution should be used when prescribing this product among patients who are receiving treatment with phenytoin and other anticonvulsants. - Capecitabine: Folinic acid (5-formyltetrahydrofolate) may increase the toxicity of Capecitabine. - Cholestyramine: Reduces folic acid absorption and reduces serum folate levels. - Colestipol: Reduces folic acid absorption and reduces serum folate levels. - Cycloserine: Reduces folic acid absorption and reduces serum folate levels. - Dihydrofolate Reductase Inhibitors (DHFRI): DHFRIs block the conversion of folic acid to its active forms, and lower plasma and red blood cell folate levels. DHFRIs include aminopterin, methotrexate, pyrimethamine, triamterene, and trimethoprim. - Fluoxetine: Fluoxetine exerts a noncompetitive inhibition of the 5-methyltetrahydrofolate active transport in the intestine. - Isotretinoin: Reduced folate levels have occurred in some patients taking isotretinoin. - L-dopa, triamterene, colchicine, and trimethoprim may decrease plasma folate levels. - Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs have been shown to inhibit some folate dependent enzymes in laboratory experiments. NSAIDs include ibuprofen, naproxen, indomethacin and sulindac. - Oral Contraceptives: Serum folate levels may be depressed by oral contraceptive therapy. - Methylprednisolone: Reduced serum folate levels have been noted after treatment with methylprednisolone. - Pancreatic Enzymes: Reduced folate levels have occurred in some patients taking pancreatic extracts, such as pancreatin and pancrelipase. - Pentamidine: Reduced folate levels have been seen with prolonged intravenous pentamidine. - Pyrimethamine: High levels of folic acid may result in decreased serum levels of pyrimethamine.
Precautions: Allergies: ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parental administration of folic acid, and may possibly occur with other forms of folate. Paresthesia, somnolence, nausea and headaches have been reported with vitamin B6. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with vitamin B12.
Precautions: All Other: Call your medical practitioner about side effects.
Precautions: All Other: - Smoking and Alcohol: Reduced serum folate levels have been noted.
Precautions: Children: KEEP THIS OUT OF THE REACH OF CHILDREN.
FDA Statement of Identity: Rx Prescription Dietary Supplement
Directions: DOSAGE AND ADMINISTRATION: One tablet twice daily or as directed by a licensed medical practitioner.
Storage: STORAGE: Store at Controlled Room Temperature 15(0)-30(0)C (59(0)-86(0)F). [See USP]. Protect from light and moisture. Dispense in a tight, light-resistant container.
Formula: Contains: Contains less than 1% d-methylfolate.
Brand information
Manufactured for: Virtus Pharmaceuticals, LLC, Tampa, FL
More labels from Virtus Pharmaceuticals
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