Label:

PROFOLA- beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, pyridoxine hydrochloride, biotin, fo...

PROFOLA- beta carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, pyridoxine hydrochloride, biotin, folic acid, levomefolate calcium, cyanocobalamin, calcium carbonate, magnesium oxide, ferrous bisglycinate, and potassium iodide tablet

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Dispensed by Prescription

ProFola is a prescription multivitamin/multimineral dietary supplement.

OTHER INGREDIENTS: Microcrystalline Cellulose, Maltodextrin, Croscarmellose Sodium, Silicon Dioxide, Stearic Acid, Magnesium Stearate, Film Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol, Titanium Dioxide, FD&C Blue # 1)

Allergen: NONE

ProFola is a prescription multivitamin/multimineral dietary supplement formulated for the clinical dietary management of suboptimal nutritional status in patients where advanced folate, vitamin B supplementation, and maintenance of good health is needed.

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

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

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 report adverse side effects or to obtain product information, contact Redmont Pharmaceuticals, LLC at 1-800-986-5909.

One tablet daily or as directed by a physician.

Bottles of 30 tablets (71741-141-301). Tablet is light blue, oblong.

1

Redmont Pharmaceuticals does not represent this product code to be National Drug Code (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirement by pedigree reporting and supply-chain control including pharmacies.

This product is a prescription-folate with or without other dietary ingredients that – 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 (38 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)

MADE IN USA

Distributed by:

Redmont Pharmaceuticals, LLC
Birmingham, AL 35209
800-986-5909

Ferrochel™ is a trademark of Albion Laboratories, Inc.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

© 2021 Redmont Pharmaceuticals, LLC
141111-0721

71741-141-30

ProFola

DIETARY SUPPLEMENT

30 TABLETS

Dispensed by Prescription