Label: FOLAGENT DHA- beta carotene, vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, potassium iodide, magnesium oxide, zinc oxide, cupric oxide, and fish oil capsule, gelatin coated

  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated April 27, 2022

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  • HEALTH CLAIM

    71741-327-30
    Multivitamin
    Dietary Supplement
    Dispensed by Prescription1

    1
    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 statutes as applicable. The ingredients, indication or claims of this product are not to be construed to be drug claims.
  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size: 1 Softgel
    Serving Per Container:
    Amount Per Serving% Daily Value
    *
    Daily Values not established
    Calories5
    Total Fat0.5 g<1%
    Cholesterol25 mg8%
    Vitamin A (50% Beta-Carotene, 50% Retinyl Palmitate)1200 mcg RAE (4000 IU)133%
    Vitamin C (as Ascorbic Acid)60 mg67%
    Vitamin D (as Cholecalciferol)10 mcg50%
    Vitamin E (as d-Alpha Tocopherol)20.1 mg (30 IU)134%
    Thiamin (B1) (from Thiamine Mononitrate)1.7 mg142%
    Riboflavin (B2)2 mg154%
    Niacin (as Niacinamide)20 mg125%
    Vitamin B6 (from Pyridoxine Hydrochloride)2.5 mg147%
    Folate (1000 mcg Folic Acid)1700 mcg DFE425%
    Vitamin B12 (as Cyanocobalamin)8 mcg333%
    Biotin300 mcg1000%
    Pantothenic Acid (from d-Calcium Pantothenate)10 mg200%
    Calcium (from Calcium Carbonate)200 mg15%
    Iron (from Carbonyl Iron)28 mg156%
    Iodine (from Potassium Iodide)150 mcg100%
    Magnesium (from Magnesium Oxide)50 mg12%
    Zinc (from Zinc Oxide)15 mg136%
    Cooper (Cooper Oxide)2 mg222%
    Eicosapentaenoic Acid (as EE) (from Fish Oil)200 mg*
    Docosahexaenoic Acid (as EE) (from Fish Oil)35 mg*

    Other Ingredients: Bovine Gelatin, Glycerin, Yellow Beeswax, Purified Water, Soy Lecithin, Annatto.

    Allergens: Fish (Anchovy, Sardine, Tuna), Soy.

    Does Not Contain: Peanuts, Tree Nuts, Shellfish, Eggs, Milk, Wheat.

  • INDICATIONS

    FolaGent DHA is prescription dietary supplement formulated for the clinical dietary management of suboptimal nutritional status in patients where advanced folate supplementation is required and nutritional supplementation in physiologically stressful conditions for maintenance of good health.

    FolaGent DHA is formulated as a prescription dietary supplement for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

  • CONTRAINDICATIONS

    This product 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: Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.
    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In 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

    Usual adult dose is 1 softgel taken orally once daily or as prescribed by a licensed medical practitioner.

  • HOW SUPPLIED

    Child-resistant bottles of 30 softgels (71741-327-302). Softgel is oblong shaped and orange reddish in color with possible dark spots.

    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)
    2
    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

    Distributed by:
    Redmont Pharmaceuticals, LLC
    Birmingham, AL 35209
    800-986-5909

    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.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

    © 2022 Redmont Pharmaceuticals, LLC

    327111-0422

  • PRINCIPAL DISPLAY PANEL - 30 Softgel Bottle Label

    71741-327-30

    FolaGent DHA

    DIETARY SUPPLEMENT

    30 SOFTGELS

    Dispensed by Prescription

    Principal Display Panel - 30 Softgel Bottle Label
  • INGREDIENTS AND APPEARANCE
    FOLAGENT DHA 
    beta carotene, vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, iron, potassium iodide, magnesium oxide, zinc oxide, cupric oxide, and fish oil capsule, gelatin coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:71741-327
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE600 ug
    Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Retinol - UNII:G2SH0XKK91) Retinol600 ug
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol10 ug
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-20.1 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.7 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin2 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide20 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride2.5 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1000 ug
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin8 ug
    Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin300 ug
    Calcium Pantothenate (UNII: 568ET80C3D) (Pantothenic Acid - UNII:19F5HK2737) Pantothenic Acid10 mg
    Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Carbonate200 mg
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron28 mg
    Potassium Iodide (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) Potassium Iodide150 ug
    Magnesium Oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) Magnesium Oxide50 mg
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide15 mg
    Cupric Oxide (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
    Fish Oil (UNII: XGF7L72M0F) (Fish Oil - UNII:XGF7L72M0F) Fish Oil235 mg
    Inactive Ingredients
    Ingredient NameStrength
    Gelatin Type B Bovine (150 Bloom) (UNII: F5AJW0ONK4)  
    Glycerin (UNII: PDC6A3C0OX)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Water (UNII: 059QF0KO0R)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    Annatto (UNII: 6PQP1V1B6O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:71741-327-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT04/22/2022
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)20 mm
    Labeler - Redmont Pharmaceuticals, LLC (080843607)
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