Other Ingredients
Microcrystalline Cellulose, Maltodextrin, Croscarmellose Sodium,®Silicon Dioxide, Stearic Acid, Magnesium Stearate, Film Coating (Hydroxypropyl®Methylcellulose, Polyethylene Glycol, itanium Dioxide, FD&C Blue# 1)
Indications
Florrvite is a prescription multivitamin/multimineral dietary supplement formulated for the clinical dietary management of a buoptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.
Contraindications
Florrvite is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Precautions
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
ALLERGIES: NONE
Adverse Reactions
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 800-000-0000.
*Florrax Pharmaceuticals does not represent this products code to be National Drug Code (NDC). 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 a prescription-folate with or without other dietary ingredients the - due to increased folate levels increased risk associated with masking B12 deficiency (pernicious anemia) requires administration under the care of a licensed medical practitioner(64 FR 8760). 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 a physician's 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 & Handling
STORAGE: Store at 20- 25 degree C (68-77 F) excersions permitted to 15 -30 degree C (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 Corp.
Terrell TX 7S161
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN
