L-Methylfolate Calcium 15 mg

Basic Information

Product Label

Product label for L-Methylfolate Calcium 15 mg
Full Name: L-Methylfolate Calcium 15 mg
Brand: Virtus Pharmaceuticals none
Product Type: Vitamin
Physical State: Tablet or Pill
UPC/SKU: 3 76439 20590 4
Product Version Code: Rev. 1/2013

Contact Information

Manufactured for

Name: Virtus Pharmaceuticals, LLC
Address:Tampa, FL, 33619
Types: Distributor

You may report side effects by calling

Phone: (813) 283-1344
Types: Other

Product Details

Net Contents

90 Tablet(s)(90 Tablet(s))

Serving Sizes

Unit:Tablet(s)
Quantity:1 - 1
Daily Servings:1 - 1

Target Groups

Adult (18 - 50 Years)

Servings Per Container

90

Ingredients & Nutrition

Calcium

non-nutrient/non-botanical

Also known as: 100 mg of calcium aspartate, 100 mg of calcium cheltate, 14 mg of ca aspartate, albion laboratories calcium chelazome., anacal, brown rice calcium amino acid chelate, brown rice calcium aminoate complex, ca aac, ca amino acid chelate, calci-quell calcium blend, calcium, {calcium} aac, calcium aac, calcium a.a. chelate, (calcium) amino acid chelate, {calcium} amino acid chelate, calcium {amino acid chelate}, calcium amino acid chelate, calcium amino acid chelate complex, calcium amino acid chelate/complex, {calcium} amino acid complex, calcium amino acid complex, calcium amino acid rice chelate, {calcium} aminoate, calcium aminoate, calcium aminoate complex, (calcium) aspartate, {calcium} aspartate, calcium aspartate, calcium aspartate anhydrous, {calcium} aspartic acid chelate, calcium asporotate, calcium-beta-hydroxy-beta-methylbutyrate, {calcium} bisglycinate, calcium bis glycinate, calcium bis-glycinate, calcium bisglycinate, calcium bisglycinate chelate, calcium bisglycinate chelate buffered, {calcium blend}, {calcium} cfmsa chelate, {calcium} chelate, calcium chelate, {calcium} chelates, calcium chelates, [calcium complex, {calcium} complex, calcium {complex}, calcium complex, calcium d-glucarate, calcium ethanolamine, calcium ethanolamine phosphate, {calcium} glycinate, calcium glycinate, {calcium} glycinate amino acid chelate, calcium glycinate amino acid chelate, {calcium} glycinate chelate, calcium glycinate chelate, {calcium} histidinate, calcium histidinate, {calcium} hvp chelate, calcium hvp chelate, {calcium} hydrolyzed protein chelate, calcium hydrolyzed protein-chelate, calcium l-aspartate, {calcium} lithothamnion, calcium l-lysinate, calcium l-threonate, {calcium} lysinate, calcium lysinate, calcium malate glycinate, (calcium) methionate, {calcium} methionate, calcium pantothenate glycinate amino acid chelate, calcium phosphate amino acid chelate, calcium rice protein chelate, calcium soy amino acid chelate, {calcium} soy amino acid chelate/complex, calcium soy amino acid chelate/complex, calcium spirulina chelate, calcium sulfate anhydrous, calcium taurate, calcium threonate, d-aspartic acid calcium chelate, from 100 mg of calcium chelate, hvp calcium chelate, koact, koact calcium collagen, koact calcium collagen chelate, koact(r) calcium collagen chelate, nitratest test matrix, organic {calcium} chelates, organic calcium chelates, ossein microcrystalline hydroxyapatite complex, protein {calcium} cholate, spirulina-bound calcium carbonate, traacs calcium bisglycinate chelate, traacs calcium glycinate chelate, trucal milk calcium complex, trucal milk calcium complex d-7

Cellulose

complex carbohydrate

Also known as: wood cellulose

Coating

other

Also known as: antioxidant coating, aqueous-based coating, aqueous based coating soluti, aqueous based coating solution, aqueous based enteric coating, aqueous-based enteric coating, aqueous cellulose film, aqueous clear coat, aqueous clear coating, aqueous clear film coating, aqueous coating, aqueous coating solution, aqueous enteric coating, aqueous enteric-coating, aqueous-enteric coating, aqueous film coating, aqueous film-coating, aqueous shellac, aqueous shellac solution, aqueous tablet coating, aqueous vegetable coating, aqueous white film coating, beige color coating, capsule & enteric coating, capsules, carboxymethylcellulose coating, carob coating, cellulose and glycerin coating:, cellulose coatiing, cellulose coating, cellulose glaze, cellulose & glycerin coating, cellulose & glycerine coating, certified organic vegetarian tablet coating, chlorophyll coating, chocolate compound coating, chocolate flavored coating, chromaseal, clear aqueous coating, clear cellulose coating, clear coating, clear enteric coating, clear film coat, clear film coating, clear food-grade coating, clear glaze, clear phamaceutical glaze coating, clear pharmaceutical glaze, clear vegetable base coating, clear vegetable coating, coating, coating:, coating agents, coating and filling materials, coating contains one or more of the following, coating ingredients, coating material, coating powder, coating solution, coating: vegetable food glaze, color film coating, confectioner's glaze, confectioners glaze, confectioners glaze coating, confectionery coating, dark chocolate coating, dark chocolate flavored coating, delayed-release tablet coating, drcaps enteric coated vegetable capsules, enteric aqueous film coating, enteric cellulose coating, enteric coated, enteric coated aqueous solution, enteric coating, enteric-coating, enteric coating aqueous solution, enteric coat with vegetable components, enteric copolymer dispersion, enteric copolymer dispersion coating, enteric film coat, enteric phase, entering coating, er caffeine coating, film coat, film coating, film coating ingredients, film coat ingredients, film ingredients, flavorless coating, flim coat, food glaze, food glaze coating, food glaze shellac, food glaze wax, food grade coating, food-grade coating, food grade enteric coating, fructose coating, glaze, glazing agent, glazing agents, glycerin coating, gras enteric coating, green cellulose film coating, green coating agent, high protein chocolate coating, high protein coating, high protein yogurt coating, hi protein reduced sugar yogurt coating, hpmc coating, kollicoat mae 30, kollicoat mae 30 dp, lemon oil coating, leucoat coating, methacrylic coating, micro wax, milk chocolate flavored coating, modified cellulose coating, natural blend coating, natural coating, natural color glaze, natural food glaze, natural glaze, natural glazing agent, natural palm leaf glaze, natural palm wax, natural protective coating, ns enteric clear, ns enteric coating, nutrapure, nutrapure organic clear coating, nutrapure organic coating, nutrateric(r) enteric coating, opadry, opadry coating, opadry ii, opadry ii blue coating, opadry ii pink, opadry ii white, opadry ns clear, opadry red, organic coating, organic coating/binder, organic film coating, organic vegetable coating, peanut flavored coating, pharmaceutical coating, pharmaceutical glaze, pharmaceutical glaze and tale, pharmaceutical glaze coating, pharmaceutical glaze no. 2, pharmaceutical resin, ph controlled enteric coated delivery system, ph resistant enteric coating, pink color coating, plant based coating, plant-based enteric coating, plant cellulose tablet coating, plant oil based coating, polyethylene glycol coating, protein coating, pure food glaze, purple coating, rapid film coat, recubrimiento vegetal, red film coating, reduced sugar dark chocolate flavored coating, resin, riboflavin coating, rice flour gelatin, serrateric, silica and film coat, silica enteric coating, sliptech clean finish, softgel and enteric coating, softgel & enteric coating, sour coating, spirulina extract (phycocyanin) coating, sugar free chocolate coating, sugar free dark chocolate coating, surelease coating, surelease ethylcellulose dispersion type b, sure-realease(tm) enteric coating, tablet coating, tablet film coating, tablet glaze coating, talc sugar loaf, transparent coating, vanilla aqueous coating, vegetab enteric coating, vegetable-based coating, vegetable-based enteric coating, vegetable-based enteric-coating, vegetable coating, vegetable food glaze, vegetable glaze, vegetable glycerin coating, vegetarian coating, vegiteric, water-soluble cellulose film coating, white aqueous base film coating, white aqueous coating, white aqueous film coating, white chocolate coating, white film coat, white film coating, white film coat ingredients, yogurt coating, yogurt flavored coating, zein protein coating

Magnesium Malate

non-nutrient/non-botanical

Also known as: albion di-magnesium malate, albion dimagnesium malate, dimagnesium, di-magnesium di-malate, di magnesium malate, di-magnesium malate, dimagnesium malate, di-magnesium malate complex, from 1000 mg magnesium malate, from di-magnesium malate, mag. malate, magnesium, magnesium malate, magnesium malate chelate, magnesium malate complex, magnesium malate dihydrate, magnesium malate trihydrate, {mg {magnesium}} malate, traacs di-magnesium malate

Silicon

non-nutrient/non-botanical

Also known as: aerosil-200, hvp {silicon} chelate, may contain silicon dioxide, {silica} amino acid chelate, silica amino acid chelate, silicon, silicon amino acid chelate, silicon aminoate, silicon hvp chelate, silicon hydrolyzed vegetable protein, silicon rice chelate

Stearic Acid

fatty acid

Also known as: non-hydrogenated vegetable stearate, octadecanoic acid, purified stearic acid, stearate, stearate acid, stearates, stearic acid, stearic acid ester, stearic acid food grade, stearic acid, powdered, stearic acid, purified, steric acid, vegetable stearic acid, vegetable stearine, vegetarian stearine, veg. stearic acid

Also known as: 5-methyletrahydrofolate, 5 methyltetrahydrofolate, 5-methyl tetrahydrofolate, 5-methyltetrahydrofolate, 5-methyltetrahydrofolate biofolate, 5-methyltetrahydrofolate calcium, 5-methyltetrahydrofolate glucosamine salt, 5-methyl-tetrahydrofolic acid, 5'-methyltetrahydrofolic acid, 5-methyltetrahydrofolic acid, glucosamine salt, 5-mthf, (6s)-5-methylfolate, (6s) 5-methyltetrahydrofolate, (6s)-5-methyltetrahydrofolate, [6s]-5-methyltetrahydrofolate, (6s)-5-methyltetrahydrofolate acid, (6s)-5-methyltetrahydrofolate-glucosamine salt, (6s)-5-methyltetrahydrofolic acid, [6s]-5-methyltetrahydrofolic acid, [6s]-5- methyltetrahydrofolic acid, (6s)-5-methyltetrahydrofolic acid, calcium salt, (6s)-5-methyltetrahydrofolic acid glucosamine salt, (6s)-5-methyltetrahydrofolic acid salt, (6s)-5-methyltetrahydrofolic calcium, 6(s)-5-mthe, (6s)-5-mthf, 6(s)-5-mthf-ca, (6s)-n5-methyltetrahydrofolic acid, (6s)-n5-methyltetrahydrofolic acid calcium salt, biofolate, calcium 5-methyltetrahydrofolate, calcium l-5-methyltetrahydrofolate, calcium-l-5 methyltetrahydrofolate, calcium-l-5-methyltetrahydrofolate, calcium l-5-mthf, calcium-l-methylfolate, calcium salt, l-5-methylfolate, folate, folate/5-mthf, folic acid, from 26 mg (6r,s)-5-methyltetrahydrofolate, from 39 mg (6r,s)-5-methyltetrahydrofolate, from 5-methyltetrahydrofolate, l-5 methylfolate, l-5-methylfolate, l-5 methyl tetrahydrofolate, l-5 methyltetrahydrofolate, l-5-methyl tetrahydrofolate, l-5-methyltetrahydrofolate, l-5 methyltetrahydrofolate calcium, l-5-methyltetrahydrofolate calcium, l-5' methyl-tetra-hydrofolate calcium, l-5-methyltetrahydrofolate calcium salt, l-5 methyltetrahydrofolic acid, l-5 methyltetrahydrofolic acid calcium salt, l-5 methyltetrahydrofolic acid, glucosamine salt, l-5 mthf, l-5-mthf, l5-mthf, l-methyfolate, l-methylfolate, l-methylfolate calcium, l-methylfolate-calcium, l-methylfolate calcium, or 6(s)-5-mthf-ca, l-methylfolate calcium salt, l-methylfolate glucosamine, l-methylfolate or 6(s)-5-mthe, l-methyltetrahydrofolate, l-methyltetrahydrofolate calcium, metafolin, metafolin l-5-methyltetrahydrofolate, metafolin l-5-methyltetrahydrofolate calcium salt, metafolin l-methylfolate, metafolin(r), metafolin(r) l-5-methyltetrahydrofolate, methyl folate, methylfolate, methyltetrafolate, methyltetrahydrofolate calcium salt, mthf, quatrefolic 5-methyltetrahydrofolate glucosamine salt, quatrefolic (6s)-5-methyltetrahydrofolate, quatrefolic (6s)-5-methyltetrahydrofolate glucosamine salt, quatrefolic (6s)-5-methyltetrahydrofolic acid, (s6)-5-methyltetrahydrofolic acid, vitamin b9

Product Statements

Precautions re: Pregnant or Nursing or Prescription Medications

If you are pregnant or nursing a baby, ask a health professional.

Precautions re: Children

KEEP THIS OUT OF REACH OF CHILDREN.

General Statements: All Other Content

All prescriptions using this product shall be pursuant to state statues as applicable. This is not an Orange Book product.

Precautions re: All Other

Call your medical practitioner about side effects.

General Statements: All Other Content

NDC* 76439-205-90 *see insert for more information on NDCs.

General Statements: All Other Content

Each coated, oblong, orange tablet contains the following dietary ingredient:

Precautions re: Allergies

This product contains FD&C Yellow #6 Lake.

General: Product/Version Code

Rev. 1/2013

FDA Statement of Identity

Prescription Dietary Supplement

FDA Statement of Identity

Rx

General Statements: All Other Content

Made in USA

Suggested/Recommended/Usage/Directions

DOSAGE AND ADMINISTRATION: The usual adult dose is 15 mg daily with or without food 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.

General Statements: All Other Content

Dispense in a tight, light-resistant container.

General Statements: All Other Content

N

General Statements: All Other Content

Lot No: Exp Date:

Precautions re: All Other

L-Methyfolate Calcium 15 mg should be administered under the supervision of a licensed medical practitioner.

Formula re: Type

DESCRIPTION: L-Methylfolate Calcium 15 mg is an orally administered prescription dietary supplement specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels.

Precautions re: 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 re: All Other

- Smoking and Alcohol: Reduced serum folate levels have been noted.

Precautions re: 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.

General Statements: All Other Content

HOW SUPPLIED: L-Methylfolate Calcium 15 mg tablets are coated, oblong, orange tablets debossed “BP” on top and “1000” on bottom, and are supplied in bottles of 90 tablets.

Precautions re: All Other

These products are dietary supplements that – due to increased folate levels (8/2/73 38 FR 20750), require an Rx on the label because of increased risk associated with masking of B12 deficiency. As such, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) as required by pedigree reporting requirements.

General Statements: All Other Content

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. Call your medical practitioner about side effects.

General Statements: All Other Content

FOLATE REGULATION: The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate, l-methylfolate, with an intermediate stable form, 5,10-methylenetetrahydrofolate. Individuals with genetic polymorphisms for the genes coding methylenetetrahydrofolate reductase (MTHFR) may not be capable of utilizing or metabolizing folic acid adequately for the vitamin B12 dependent methylation cycle. Folic acid, including reduced forms such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision of a licensed medical practitioner. The 1971, 1972, 1973, 1980, 1984, 2000, and 2010 Federal Register Notices addressed this concern while establishing that increased folate was proper therapy in megaloblastic anemias - specifically where homocysteine levels were elevated or risk of neural tube defects (NTDs) was at issue. The Federal Register Notice of August 2, 1973 (38 FR 20750) specifically states that: Dietary supplement preparations are available without a prescription (21 CFR 121.1134). Levels higher than dietary supplement amounts are available only with a prescription.

Precautions re: All Other

It is not known whether or not l-methylfolate can obscure pernicious anemia above 0.1 mg doses, so caution is advised also with this form of folate.

General Statements: All Other Content

Folic acid - including reduced forms, may be added to medical foods as defined in section 5(b)(3) of the Orphan Drug Act (21 USC 360ee(b)(3)), or to food (21 CFR 172.345).

Suggested/Recommended/Usage/Directions

INDICATIONS AND USAGE: L-Methylfolate Calcium 15 mg is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. L-Methylfolate Calcium 15 mg should be administered under the supervision of a licensed medical practitioner.

Precautions re: Pregnant or Nursing or Prescription Medications

PREGNANCY and NURSING MOTHERS: L-Methylfolate Calcium 15 mg is not intended for use as a prenatal/postnatal multivitamin for lactating and non-lactating mothers. This product contains a B vitamin in reduced form. Talk with your medical practitioner before using if pregnant or lactating.

Precautions re: 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.

Suggested/Recommended/Usage/Directions

DOSAGE AND ADMINISTRATION: The usual adult dose is 15 mg daily with or without food or as directed by a licensed medical practitioner.

General Statements: All Other Content

NDC 76439-205-90 (90 ct. bottle / 90 tablets)

Precautions re: All Other

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. 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. A major depressive episode may be the initial 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 a mixed/manic episode in patients at risk for bipolar disorder. L-Methylfolate Calcium 15 mg is not an antidepressant; however, folate 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.

Precautions re: All Other

PATIENT INFORMATION: L-Methylfolate Calcium 15 mg is a prescription dietary supplement to be used only under licensed medical supervision.

General Statements: All Other Content

L-Methylfolate Calcium 15 mg Tablets Rx Prescription Dietary Supplement 90 ct. Bottle (90 tablets)

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