Ferrex 150 Forte Plus Capsulesnone

Suggested/Recommended/Usage/Directions

Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: Clinical studies on this product have not been performed in subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elder patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Suggested/Recommended/Usage/Directions

Dosage and administration: Usual adult dosage is 1 capsule daily, or as directed by a physician or health-care provider.

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: Contains

Sumalate (Ferrous Asparto Glycinate) is a registered trademark of Albion International Inc., Clearfield, Utah and is licensed exclusively to Breckenridge Pharmaceutical, Inc., for certain iron products.

FDA Statement of Identity

Medical Food

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)

Indications and usage: Ferrex 150 Forte Plus Capsules are indicated for the dietary management of individuals with distinct nutritional needs for iron deficiencies and/or nutritional megaloblastic active and ongoing medical supervision requiring medical care on a recurring basis for, among other things, instructions on the use of the medical food.

General Statements: All Other Content

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 the 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.

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

How supplied Ferrex 150 Forte Plus Capsules are available as a white/red capsule, imprinted "B 798". Supplied in bottles of 90 capsules, 51991-798-90.

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

U.S. Patent Nos. 5,516,925; 6,716,814; 8,007,846. Other U.S. patents pending.

General: Product/Version Code

Rev. 6/11