Label: FOLAPRIME- 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

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated July 15, 2024

If you are a consumer or patient please visit this version.

  • STATEMENT OF IDENTITY

    FolaPrime 71741-382-30
    Multivitamin Dietary Supplement
    Dispensed by Prescription

  • DESCRIPTION

    FolaPrime is a prescription multivitamin/multimineral dietary supplement.

  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving size 1 Tablet
    Amount per Serving:%Daily Value
    *
    Daily Value not established
    Vitamin A (as Beta-Carotene)300 mcg RAE33%
    Vitamin C (as Ascorbic Acid)60 mg67%
    Vitamin D (as Cholecalciferol)10 mcg50%
    Vitamin E (as dl-Alpha Tocopherol Acetate)4.5 mg (10 IU)33%
    Vitamin B6 (as Pyridoxine HCl)26 mg1529%
    Biotin0.280 mg933%
    Folate1.67 mg DFE418%
      (from Folic Acid)0.67 mg DFE*
      (from 5-Methyl Tetrahydrofolate, Calcium Salt)1 mg DFE*
    Vitamin B12 (as Cyanocobalamin)0.013 mg542%
    Calcium (as Calcium Carbonate)80 mg6%
    Magnesium (as Magnesium Oxide)25 mg6%
    Ferrochel™ Iron (as Ferrous BisGlycinate Chelate)20 mg111%
    Iodine (as Potassium Iodide)0.150 mg100%

    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

  • INDICATIONS

    FolaPrime 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.

  • CONTRAINDICATIONS

    FolaPrime 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 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.

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

  • DOSAGE AND ADMINISTRATION

    One tablet daily or as directed by a physician.

  • HOW SUPPLIED

    Bottles of 30 tablets (71741-382-301). Tablet is blue, oblong.

    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)

    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.
  • STORAGE AND HANDLING

    STORAGE

    Store at 20°-25° C (68°-77°F) excursions permitted to 15°-30°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.

  • HEALTH CLAIM

    MADE IN USA

    Distributed by:

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

    Ferrochel™ is a trademark of Albion Laboratories, Inc.

    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.
  • SAFE HANDLING WARNING

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

  • HEALTH CLAIM

    © 2024 Redmont Pharmaceuticals, LLC
    382111-0624

  • PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

    71741-382-30

    FolaPrime
    DIETARY SUPPLEMENT

    30 TABLETS

    Dispensed by Prescription

    Principal Display Panel - 30 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    FOLAPRIME 
    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
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:71741-382
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE300 ug
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol10 ug
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE4.5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE26 mg
    Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin0.28 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid0.4 mg
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLATE CALCIUM0.6 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin0.013 mg
    Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Cation80 mg
    Magnesium Oxide (UNII: 3A3U0GI71G) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Cation25 mg
    FERROUS BISGLYCINATE (UNII: SFW1D987QV) (Ferrous Cation - UNII:GW89581OWR) Ferrous Cation20 mg
    Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q) Potassium Iodide0.15 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:71741-382-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT07/10/2024
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)19 mm
    Labeler - Redmont Pharmaceuticals, LLC (080843607)