Folbee Plusnone

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.

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.

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.

Formulation re: Does NOT Contain

Sugar and lactose free

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.

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.

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.

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.

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.

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.