L-Methylfolate Calcium Tablets are labeled as a medical food for the distinct nutritional requirements of individuals who have or are at risk for hyperhomocysteinemia and other conditions relating to suboptimal L-methylfolate levels.
The usual adult dose is 7.5 mg (12,750 mcg DFE) to 15 mg (25,500 mcg DFE) given daily with or without food or as directed under medical supervision.
L-Methylfolate Calcium Tablets are a medical food for the dietary management of conditions relating to sub-optimal L-methylfolate levels, recommended for use under the supervision of a physician or healthcare provider.
| Each L-Methylfolate Calcium 7.5 mg tablet contains: | |
| Folate (L-methylfolate Calcium 7.5 mg) | 12,750 mcg DFE |
| Each L-Methylfolate Calcium 15 mg tablet contains: | |
| Folate (L-methylfolate Calcium 15 mg) | 25,500 mcg DFE |
L-Methylfolate Calcium 7.5 mg Other Ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Hydroxypropyl Methylcellulose, Titanium Dioxide, Silicon Dioxide, Polydextrose, Magnesium Stearate, Triacetin, Polyethylene Glycol, FD&C Blue #1 Aluminum Lake, and FD&C Blue #2 Aluminum Lake.
L-Methylfolate Calcium 7.5 mg tablets do not contain sugar, lactose, yeast or gluten.
L-Methylfolate Calcium 15 mg Other Ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Hydroxypropyl Methylcellulose, Silicon Dioxide, Polydextrose, Titanium Dioxide, Magnesium Stearate, Triacetin, FD&C Yellow #6 Aluminum Lake, Polyethylene Glycol.
L-Methylfolate Calcium 15 mg tablets do not contain sugar, lactose, yeast or gluten.
* Contains FD&C Yellow No. 6 as a color additive
L-Methylfolate Calcium is labeled as a medical food for use under the active and ongoing medical supervision of a physician or health-care provider on a recurring basis for, among other things, instructions on their use.
Medical foods are intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone.1 This Medical Food is not subject to NDA or ANDA approval and is not an Orange Book product. Although FDA does not require a prescription for Medical Foods, this product is intended to be used under active medical supervision. This product is not eligible for government reimbursement under federal programs, but is eligible for reimbursement under state programs on a case-by-case basis. Please check with a specific state to determine proper reimbursement eligibility.
| These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. |
L-Methylfolate Calcium is a medical food, which consists of a proprietary biologically active folate, derived from food sources.
L-Methylfolate Calcium Tablets are labeled as a medical food for the distinct nutritional requirements of individuals who have or are at risk for hyperhomocysteinemia and other conditions relating to suboptimal L-methylfolate levels.
L-Methylfolate Calcium is contraindicated in patients with known hypersensitivity to any of the components contained in this product.
Folic acid, when administered in daily doses above 0.1 mg, 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). L-methylfolate may be less likely than folic acid to mask vitamin B12 deficiency.2,3 Folate therapy alone is inadequate for the treatment of a B12 deficiency.
L-Methylfolate Calcium is a medical food1 for use under the medical supervision of a physician or health-care provider.
Before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. No decrease in effectiveness of drugs has been reported with the use of L-Methylfolate Calcium.
L-Methylfolate Calcium contains folate, which may have interactions with the following:
Allergic reactions have been reported following the use of oral L-methylfolate Calcium.14
Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
The usual adult dose is 7.5 mg (12,750 mcg DFE) to 15 mg (25,500 mcg DFE) given daily with or without food or as directed under medical supervision.
L-Methylfolate Calcium is a medical food for use under the supervision of a physician or healthcare provider.
L-Methylfolate Calcium 7.5 mg is a round light-blue tablet, imprinted with "280" on one side and blank on the other side.
Bottles of 30 Product Code 69367-280-301 Use under medical/physician supervision.
Bottles of 90 Product Code 69367-280-091 Use under medical/physician supervision.
L-Methylfolate Calcium 15 mg is an orange oval-coated tablet, imprinted with "281" on one side and blank on the other side.
Bottles of 90 Product Code 69367-281-091 Use under medical/physician supervision.
1 Westminster Pharmaceuticals, LLC. does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirements of pharmacy and health insurance computer systems.
Store at 25°C (77°F), excursions permitted 15°C to 30°C (59°F to 86°F) See USP Controlled Room Temperature. Protect from light and moisture.
To report a serious adverse event contact: 1-844-221-7294
Manufactured for:
Westminster Pharmaceuticals , LLC
Nashville, TN 37217
7357 & 7358
Rev 08/2021
69367-281-09
L-Methylfolate
Calcium Tablets
15 mg
Do not use this product if the safety seal
under this cap is torn, broken or missing.
Medical Food
90 Tablets
Westminster
Pharmaceuticals
69367-280-09
L-Methylfolate
Calcium Tablets
7.5 mg
Do not use this product if the safety seal
under this cap is torn, broken or missing.
Medical Food
90 Tablets
Westminster
Pharmaceuticals
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69367-281-09 | EA - Each | 69367-281 | 18a9011d-2b31-4234-94f0-5b4e52ddda48 | 1 | 2022-10-06 |
| 69367-280-09 | EA - Each | 69367-280 | 1e674526-3790-4eb3-88b2-e8d41487300b | 1 | 2022-10-06 |
| 69367-280-30 | EA - Each | 69367-280 | 4a26650c-9e66-4096-95a8-3d8a28a466b0 | 1 | 2022-10-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69367-281 | 69367-281-09 |
| 69367-280 | 69367-280-30, 69367-280-09 |
Every source-derived ingredient row is available through these pages.
Adverse event summaries are temporarily unavailable. Other product information remains available.