FDA Label for Vitacore
View Indications, Usage & Precautions
Vitacore Product Label
The following document was submitted to the FDA by the labeler of this product Florrax Pharmaceutical Corp.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Vitacore is a prescription multivitamin/multimineral dietary supplement.
Indications & Usage
Vaticore is a prescription multivitamin/multi-mineral dietary supplement formulated for the clinical dietary management of a subuoptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.
Contraindications
Vaticore 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. Felic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
Warnings
WARNING Accidental overdose of iron-containing products is a 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 a doctor or poison control center immediately.
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 888-321-2821.
Dosage & Administration
One tablet daily or as directed by a physician.
How Supplied
Bottles of 30 Tablets (84460-901-30). Tablet is light blue, oblong.
Other
*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 and Handing
Storage And 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
Dallas, TX 75161
Other Safety Information
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN
Package Label.Principal Display Panel
* Please review the disclaimer below.
