Folbee Plus

Basic Information

Product Label

Product label for Folbee Plus
Full Name: Folbee Plus
Brand: Breckenridge Pharmaceutical none
Product Type: Vitamin
Physical State: Tablet or Pill
UPC/SKU: 3 51991 08290 3
Product Version Code: Rev. 01/13

Contact Information

Distributed by

Name: Breckenridge Pharmaceutical, Inc.
Address:Boca Raton, FL, 33487
Types: Distributor

Manufactured by

Name: Contract Pharmacal Corp.
Address:Hauppauge, NY, 11788
Types: Manufacturer

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)Sugar Free

Ingredients & Nutrition

Biotin

vitamin

Also known as: biotin, biotin dicalcium phosphate, biotin, natural, biotin, pure, biotin, pure crystalline, d-biotin, d-biotin, natural, liposomal biotin, orgen-bio, super biotin, vitamin b7, vitamin b7, powder, vitamin h

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

capsule

other

Also known as: 100% gelatin capsule, 100% hypromellose capsule, 100% kosher vegetable capsules, 100% pure vegetable source cellulose, 100% vegetable base capsules, 100% vegetable capsule, 100% vegetarian capsule, 100% vegetarian capsules, acid-resistant capsule, acid-resistant cellulose capsule, acid resistant vegetarian capsule, all natural vegetarian capsule, beef gelatin capsule, bioxtend capsule, bovine gelatin capsule, bovine gelatin capsules, bovine gelatine, bse-free gelatin capsules, caplique capsule, capsule, capsule:, capsule constituents, capsule material, (capsules), capsules, capsules cellulose, capsule shell, capsule shell contains, capsules of plant origin, caramel colored gelatin softgel, cellulose, cellulose capsule, cellulose capsules, cellulose ethers, cellulose gelatin, cellulose (plant) capsule, cellulose (vegetable) capsule, cellulose vegetable capsule, cellulose vegetarian capsule, cellulose vegetarian capsule shell, cellulose vegi-capsule, certified halal and kosher gelatin capsules, certified organic tapioca pullulan capsule, certified organic vegetarian capsule, certified vegetarian capsules, chlorophyll, chlorophyll capsule, chlorophyll vegetable capsule, choline capsule, choline-stabilized orthosilicic acid capsule, clear gelatin capsule, clear natural veggie capsules, clear vegetarian capsule, clear veggie cap rice flour, delayed release capsule, delayed-release capsule, delayed-release capsules, delayed release capsule technology, delayed release vegetable capsule, delayed release vegetarian capsule, delayed-release vegetarian capsule, drcaps, drcaps capsule, drcaps capsules, dr capsule, drcaps vegetable capsule, dr vegetarian capsule, each light-resistant caramel-coated gelatin softgel, each light-resistant caramel-coated gelatin softgel contains, each light-resistant caramel-coated gelatin softgel contains unrefined and unfiltered, embo caps ap, embo cap vg, encapsulated in a gelatin capsule, encapsulated in a soft gelatin capsule, encapsulated in a softgel capsule, enteriprure(tm) softgel, enteripure softgel, fermented tapioca, fish gelatin, fish gelatin caplique capsule, fish gelatin capsule, fish oil capsule shell, fish (salmon) gelatin capsule, gelatin, gelatin and water, gelatin caplique capsule, gelatin caps, gelatin capsule, gelatin capsule '00', gelatin capsules, gelatin capsule shell, gelatine caps, gelatine capsule, gelatine capsules, gelatine capsule shell, gelatin free capsule, gelatin red capsules, gelatin shell, gelatin softgel, gelatin softgel capsule, {gelcap}, gelcap, gel capsule, gel capsule with polymer enteric coat, gel shell, glycerin, glycerin gelcap, glycerin (vegetable source) and lycopene gelcap, glycerin (vegetable source) gelcap, green and yellow capsule, green (chlorophyll) vegetable capsules, hard gelatin capsules, hard shell capsule, hardshell capsule, hpmc, hpmc capsule, hpmc capsules, hpm cellulose, hpmc vegetable capsule, hpmc vegetable capsules, hpmc vegetarian capsule, hydroxpropyl methylcellulose, hydroxypropyl methylcellulose, hydroxypropylmethylcellulose, hydroxypropyl methylcellulose capsule, hydroxypropyl methylcellulose (vegatable) capsule, hydroxypropyl methylcellulose (vegatable) capsules, hydroxypropyl methylcellulose (vegetable) capsule, hydroxypropyl methylcellulose (vegetable) capsules, hydroxypropyl methylcellulose (veggie) capsule, hypromellose, hypromellose capsule, hypromellose capsules, hypromellose vegetable capsule, in a gelatin capsule, in a softgel capsule, in a vegetable cellulose capsule, in a vegetarian capsule, ingredients are contained in a vegetarian approved capsule, just a vegetable capsule, kosher capsule, kosher certified capsules, kosher certified gelatin capsules, kosher certified vegetarian capsule, kosher certified vegetarian capsules, kosher gelatin capsule, kosher gelatin capsules, kosher vegetable capsule, kosher vegetable capsules, l-carnitine capsule, liposomes, liquid gel capsule, liquid veggie capsule, lycopene gelcap, marine gelatin capsule, methylcellulose, methylcellulose capsule, methylcellulose (vegetable) capsules, microcrystalline hydroxyapatite concentrate with vitamins d3 and k2 capsule, mindcare life micronutrient capsule, mindcare protect micronutrient capsule, modified cellulose capsule, modified cellulose capsule shell, modified plant cellulose, natural gelatin capsules, natural plant cellulose, natural plant cellulose (acid resistant) vegetarian capsule, natural polysaccharide capsule, natural pullulan polysaccharide capsule, natural vegetable capsules, natural veggie capsule, non-gmo capsule, non-gmo plantgel softgel, non-gmo softgel, non-gmo softgel capsule, non-gmo vegan capsule, non-gmo vegetable cellulose capsule, non-gmo vegetable cellulose dual-layer capsules, non-gmo vegetarian capsule, non-gmo vegetarian capsules, non-organic vegetable (polysaccharide) capsule, npcaps(r) capsules, nutricaps pullulan capsule, omega-3 epa & dha capsule, omegagenics epa-dha 720 softgel, omegagenics neuro 1000 softgel, organic capsule, organic capsules, organic certified vegetarian capsules, organic pullulan capsule, organic vegetable pullulan capsules, organic vegetarian capsule, organic vegetarian capsules, organic veggie capsule, other ingredients for choline-stabilized orthosilicic acid capsule, other ingredients for microcrystalline hydroxyapatite concentrate with vitamins d3 and k2 capsule, other ingredients for ossopan 1100 with vitamins d3 and k2 capsule, other ingredients for osteoblox cf, outer shell, pfizer capsules, pharmaceutical grade kosher and halal gelatin capsules, plant based capsule, plant-based capsule, plant based tapioca capsule, plant based tapioca capsules, plant-based vegetarian capsule, plantcap, plantcaps non-gmo fermented tapioca starch capsule, plant capsule, plant capsules, plantcaps vegetarian capsules, plant cellulose, plant cellulose capsule, plant cellulose capsules, plant derived capsule, plant-derived capsule, plant-derived capsule., plant-source capsule, plant-source capsules, plusone prenatal multi capsule, polysaccharide capsule, pullulan, pullulan capsule, pullulan capsules, pullulan vegetable capsule, pullulan vegetarian capsule, pullulan vegetarian capsules, purified water, purified water and glycerin (vegetable source) gelcap, shell, shell ingredients, silicon dioxide gelatin caps, size 1 vegetable capsule, soft capsule gelatin, {soft-gel}, soft gel, soft-gel, softgel, soft gelatin, soft gelatin capsule, soft-gelatin capsule, soft gel capsule, soft-gel capsule, softgel capsule, softgel capsule:, softgel capsules, softgel consists of, softgel contains, softgel ingredients, softgel ingredients:, softgels, soft gel shell, soft gel shell:, softgel shell, softgel shell:, special kosher colostrum gel caps, starch, tapioca capsule, targeted release capsule, tetrasorb delivery, turmeric, usp kosher gelatin capsule, usp kosher gelatin capsules, v cap, vcap plus, vcaps plus vegetarian capsule, vcaps(r) capsules, vcaps(tm) capsule, vcaps(tm) cellulose capsule, vegagels(r), vegancaps, vegancaps(tm), vegan capsule, vegan capsules, vegancap(tm), vegan gel shell, vegan liquid capsule, vegan pullulan capsule, vegan softgel, vegan-softgel, vegan softgel capsule, vegan softgel shell, vegatable capsule, veg cap, veg. capsule, veg. capsules, vege capsule, vegetable based capsule, vegetable-based capsule, vegetable caps, vegetable capsule, vegetable capsule (modified cellulose) cellulose, vegetable capsules, vegetable capsule shell, vegetable capsules shell, vegetable cellulose, vegetable (cellulose) capsule, vegetable cellulose capsule, vegetable cellulose capsules, vegetable-derived polysaccharide, vegetable gelatin, vegetable gelatin capsule, vegetable gel shell, vegetable hypromellose capsule, vegetable hypromellose drcaps, vegetable-origin capsule, vegetable polysaccharide, vegetable polysaccharide capsule, vegetable polysaccharides, vegetable pullulan, vegetable softgel, vegetable softgel:, vegetable softgel capsule, vegetarian acid-resistant capsule, vegetarian caplet, vegetarian caplique capsule, vegetarian caplique (symbols) capsule, vegetarian capsule, vegetarian capsule hpmc vegetarian capsule, vegetarian capsules, vegetarian capsule shell, vegetarian cellulose, vegetarian cellulose capsule, vegetarian delayed release capsule, vegetarian gelatin, vegetarian gelatin capsule, vegetarian gelatin capsules, vegetarian inner capsule, vegetarian outer capsule, vegetarian pullulan capsule, vegetarian size 1, plantcap capsule, (vegetarian softgel), vegetarian soft gel, vegetarian softgel, vegetarian softgel capsule, vegetarian softgels, vegetarian source capsules, vegetarian vcaps(r) capsule, vegetarian v-capsule material, vegetarian (vegan) capsules, veggie cap, veggie capsule, veggie capsules, veggie gelcap, veggie softgel, veggie softgel capsule, vegicap, vegi capsule, veg-softgel, vegtab, vsoftgel, water, water and vegan capsule

Cellulose

complex carbohydrate

Also known as: wood cellulose

Also known as: hydrated magnesium silicate, magensium silicate, magnesium silica, magnesium silicate, magnesium silicate hydroxide, magnesium silicate powder, magnesium sillicate, magnesium slicate, magnesium trisilica, magnesium trisilicate, magnesium trisillicate, natural magnesium silicate, purified talc, silicato de magnesio, talc, talc, powder, talc, purified, talcum, vegetable magnesium silicate, veg. magnesium silicate

Magnesium Stearate

non-nutrient/non-botanical

Also known as: magnesium stearate

Also known as: light mineral oil, mineral oil, mineral oil, powder

Nicotinamide

Botanical

Also known as: niacin, niacinamide, niacinamide, natural, niacin b3, niacin, granular, nicotinamide, nicotinamide riboside, nicotinamide riboside chloride, vitamin b3, natural

Also known as: d-pantothenic acid, pantethine, pantothenate, pantothenate, natural, pantothenic acid, pantothenic acid, natural, vitamin b5

Also known as: pyridoxine, vitamin b6, vitamin b-6 complex

Also known as: riboflavin, riboflavin-5’-phospate sodium, riboflavin 5' phosphate, riboflavin b2, vitamin b2

Also known as: sodium laurel sulfate, sodium lauryl sulfate, sodium lauryl sulphate

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

Thiamin

Botanical

Also known as: thiamine, thiamine monophosphate chloride

Titanium Dioxide

non-nutrient/non-botanical

Also known as: titanium dioxide

Triacetin

non-nutrient/non-botanical

Also known as: glycerol triacetate, glyceryl triacetate, glyceryl triacitate, triacetin

Also known as: 5-adenosylcobalamin, 5'-deoxyadenosylcobalamin, adenosyl b12, adenosylcobalamin, cobalamin, cobalamin concentrate, cobamamide, coenzyme b12, coenzyme vitamin b12, co-methylcobalamin, cyanocobalamin, cyanocobalamin, natural, dibencozide, hydroxocabalamin acetate, hydroxocobalamin, hydroxocobalamin acetate, hydroxocobalamin hydrochloride, hydroxycobalamin, mecobalactive, mecobalamin, methyl b12, methylcobalamin, methylcobalamin, active, methylcobalamin dicalcium phosphate, methylcobalamin, natural, methylcobalamin, pure, mixed cobalamin, mixed cobalamin, natural, nutrigenesis, poten-zyme vitamin b12, proprietary coenzyme b12, vitamin b12, vitamin b12, natural

Also known as: coenzyme folic acid, controlled release citrate d-pteroylmonoglutamic acid, cultured folic acid, folacin, folate, folic acid, folic acid b-9, folic acid dicalcium phosphate, folic acid trituration, levomefolic acid, liposomal vitamin b9, organic folic acid, poten-zyme(r) foiic acid, poten-zyme(r) folic acid, pteroylglutamic acid

Also known as: ascorbate palmitate, buffered vitamin c, buffered vitamin c ascorbate, calcium strontium ascorbate, l-ascorbate c crystals, vitamin c

Product Statements

Suggested/Recommended/Usage/Directions

Dosage and administration: Usual adult dosage is one tablet daily, between meals, or as directed by a physician or health-care provider. For dialysis patients, Folbee Plus should be taken daily. On dialysis days, Folbee Plus Tablets should be taken after dialysis treatment.

Precautions re: Pregnant or Nursing or Prescription Medications

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.

FDA Disclaimer Statement

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.

Precautions re: Children

Warning: 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.

Brand IP Statement(s) re: (c), (TM), (SM)

Some or all of the following patents may apply: U.S. Patent No. 4,940,658; U.S. Patent No. 5,563,126; U.S. Patent No. 5,795,873; U.S.Patent No. 6,207,651; U.S. Patent No. 6,297,224; U.S. Patent No. 6,528,496 and other pending patent applications.

General Statements: All Other Content

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

Precautions re: All Other

To report a serious adverse event contact: 1-800-367-3395.

Formulation re: Does NOT Contain

Sugar and lactose free

Precautions re: All Other

Do not use this product if the inner safety seal under the cap is torn, broken or missing.

General Statements: All Other Content

Medical food

General Statements: All Other Content

How supplied Folbee Plus Tablets are available as a yellow, film-coated, capsule-shaped tablet, debossed "B 082" in bottles or 90 tablets, 51991-082-90.

Storage

Store at 25(0)C (77(0)F); excursions permitted to 15(0)-30(0)C (59(0)-86(0)F). See USP controlled room temperature. Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

Formula re: Type

Indications and usage: For the dietary management of individuals with distinct nutritional needs under a physician or health-care provider's supervision for end stage renal failure, dialysis, hyperhomocysteinemia or inadequate dietary vitamin intake.

Suggested/Recommended/Usage/Directions

Forbee Plus Tablets are labeled as a medical food intended for use under active and ongoing medical supervision requiring medical care on a recurring basis for, among other things, instructions on the use of the medical food.

Precautions re: All Other

This product is recommended for use under the supervision of a physician, or health-care provider.

Formula re: Type

Medical foods: 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 a normal diet alone. Although a medical-food product is intended for use under the active and ongoing medical supervision, FDA does not require a prescription.

Precautions re: All Other

Contraindications: Known hypersensitivity to any of the components in the products is a contraindication.

Precautions re: All Other

Warnings: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

Precautions re: All Other

Do not exceed recommended dosage. Precautions: Folic acid when administered as a single agent in doses above 0.1 mg daily, may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 1 mg of cyanocobalamin contained in Folbee Plus Tablets has been shown to provide an adequate amount of cyanocobalamin to address this precaution. 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 Folbee Plus Tablets.

Formula re: Contains

Precautions: Folic acid when administered as a single agent in doses above 0.1 mg daily, may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. The 1 mg of cyanocobalamin contained in Folbee Plus Tablets has been shown to provide an adequate amount of cyanocobalamin to address this precaution. 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 Folbee Plus Tablets.

Precautions re: Allergies

Adverse reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Paresthesia and somnolence have been reported with pyridoxine hcl. Mild transient diarrhea, polycythemia vera, peripheral vascular thrombosis, itching transitory exanthema and feeling or swelling of entire body has been associated with cyanocobalamin.

Precautions re: Pregnant or Nursing or Prescription Medications

Drug interactions: Pyridoxine supplements 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 preparations containing both carbidopa and levodopa. Concurrent use of phenytoin and folacin (folic acid) may result in decreased phenytoin effectiveness.

Precautions re: All Other

Patient information: Folbee Plus Tablets are for use only under the direction and supervision of a licensed physician or health-care provider.

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