LEVOMEFOLATE CALCIUM-PYRIDOXAL PHOSPHATE-MECOBALAMIN- levomefolate calcium, pyridoxal phosphate, and methylcobalamin tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC), PYRIDOXAL PHOSPHATE (UNII: 5V5IOJ8338) (PYRIDOXINE - UNII:KV2JZ1BI6Z), METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W)

Available from:

Westminster Pharmaceuticals, LLC

Administration route:

ORAL

Therapeutic indications:

L-Methyl-B6-B12 Tablets are indicated for the distinct nutritional requirements of patients with endothelial dysfunction. L-Methyl-B6-B12 Tablets are indicated for the distinct nutritional requirements of patients with hyperhomocysteinemia. There have been rare reports of hypersensitivity (allergic-like reactions) to L-Methyl-B6-B12 Tablets . Therefore, a known hypersensitivity to any of the components in the product is a contraindication to its use for any indication.

Product summary:

L-Methyl-B6-B12 Tablets is available as a round, coated purple-colored tablet. Debossed with "282" on one side and plain on the other. Bottles of 90 tablets Product Code 69367-282-091 Use under supervision of a physician or health-care provider. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from heat, light and moisture.

Authorization status:

MEDICAL FOOD

Summary of Product characteristics

LEVOMEFOLATE CALCIUM-PYRIDOXAL PHOSPHATE-MECOBALAMIN-
LEVOMEFOLATE CALCIUM, PYRIDOXAL PHOSPHATE, AND METHYLCOBALAMIN TABLET,
COATED
WESTMINSTER PHARMACEUTICALS, LLC
----------
L-METHYL-B6-B12 TABLETS
L-METHYL-B6-B12 TABLETS is a medical food for the dietary management
of endothelial
dysfunction.
DESCRIPTION
Each round, coated purple colored tablet contains:
Folate (L-methylfolate
Calcium 3 mg)
5,100 mcg DFE
Pyridoxal-5'-Phosphate
35 mg
Methylcobalamin
2 mg
OTHER INGREDIENTS: Microcrystalline Cellulose, Pregelatinized Starch,
Hydroxypropyl
Methylcellulose, Silicon Dioxide, Polydextrose, Titanium Dioxide,
Magnesium Stearate,
Triacetin, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, and
Polyethylene Glycol.
L-METHYL-B6-B12 TABLETS do not contain sugar, lactose, yeast or
gluten.
L-METHYL-B6-B12 TABLETS 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. 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.
IN