ADVERSE REACTIONS SECTION.

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about serious adverse events. To reports adverse side effects or to obtain product information, contact Florrax Pharmaceuticals at 888-321-2821.

CONTRAINDICATIONS SECTION.

Florraxyl is contraindicated in patients with known hypersensitivity to any of the ingredients.

DESCRIPTION SECTION.

Florraxyl is prescription multivitamin/multimineral dietary supplement.

DOSAGE & ADMINISTRATION SECTION.

One tablet daily or as directed by physician.

HOW SUPPLIED SECTION.

Bottles of 30 Tablets (84460-903-30). Tablet is light blue, oblong.

INDICATIONS & USAGE SECTION.

Florraxyl is prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of buoptimal nutritional status in patients where advanced folate, vitamin supplementa-tion, and maintenance of good health is needed.

PRECAUTIONS SECTION.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin 12 deficient. Felic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

SPL UNCLASSIFIED SECTION.

Florrax Pharmaceuticals does not represent this products code to be National Drug Code INDC). Products codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies. This products is prescription-folate with or without other dietary ingredients the due to increased folate levels increased risk associated with masking 12 deficiency (pernicious anemia) requires administration under the care of licensed medical practitioner(64 FR 87 60). 1-3 the most appropriate way to ensure pedigree reporting consistent with these regulatory guidelines and safety monitoring is to dispense this product only by prescription. This is not an Orange Book product. This product may be administered only under physicians supervision and all prescriptions using this product shall be pursuant to state statues as applicable. The ingredients, indication or claims of this product are not to be construed to be Drug claims. 1.) Federal register Notice of August 2, 1973 (39 FR 20750) 2.) Federal Register Notice of October 17, 1980 (45 FR 69043, 69044) 3.) Federal register notice of March 5, 1996 (61 FR 8760).

STORAGE AND HANDLING SECTION.

STORAGE: Store at 20- 25 degree (68-77 F) excersions permitted to 15 -30 degree (59-86 F) See USP controlled Room Temperature Avoid excessive heat, light and moisture. TAMPER EVIDENT: Do not use if seal is broken or missing. MADE IN USA Distributed by: 888-321-2821 Florrax Pharmaceutical Dallas, TX 75161 KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

WARNINGS AND PRECAUTIONS SECTION.

Accidental overdose of iron-containing products is leading cause of fatal poising in children under 6. Keep this product out of the reach of children. In the case of accidental overdose, call doctor or poison control center immediately.