Label: FOLCYTEINE- multivitamin tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 14, 2023

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  • DESCRIPTION:

    Each caplet contains:
    Vitamin D3 (as Cholecalciferol) .................. 20 mcg (800 IU)
    Folate (as Folic Acid)...1,667 mcg DFE (1,000 mcg Folic Acid)
    Calcium (as Calcium Citrate)....................................... 47 mg
    Magnesium (as Magnesium Citrate)........................... 16 mg
    N-Acetyl-L-Cysteine................................................... 200 mg

  • Other Ingredients:

    Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Sodium Carboxymethyl Starch, Stearic Acid, Coating: (Hydroxypropyl Methylcellulose, PEG-8).

  • Indications and Usage:

    Folcyteine™ is indicated to provide vitamin supplement to men and women. Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood

  • Contraindications:

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Folcyteine™ is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

  • BOXED WARNING (What is this?)

    Warnings:

    Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor. Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.

    Precautions

    Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. There is a potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

    For use on the order of a healthcare practitioner.

    Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • 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 PureTek Corporation, at 1-877-921-7873.

  • Dosage and Administration:

    One (1) Folcyteine™ caplet daily or as directed by a physician. Do not administer to children under the age of 12.

  • How Supplied:

    Folcyteine™ are pale yellow, clear coated caplets in bottles containing 30 caplets – NDC 59088-795-54. Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure.

  • Storage

    Do not use if bottle seal is broken.

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

    Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.

    To report a serious adverse event or to obtain product information, contact 877-921-7873.

    Manufactured by:

    PureTek Corporation Panorama City, CA 91402

    For questions or information call toll-free: 877-921-7873

  • Folcyteine™

    Manufactured in the USA by:
    PureTek Corporation
    Panorama City, CA 91402
    For questions or information
    call toll-free: 877-921-7873

    label

  • INGREDIENTS AND APPEARANCE
    FOLCYTEINE 
    multivitamin tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-795
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CITRATE (UNII: MLM29U2X85) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CITRATE47 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL800 [iU]
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1000 ug
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC) (ACETYLCYSTEINE - UNII:WYQ7N0BPYC) ACETYLCYSTEINE200 mg
    MAGNESIUM CITRATE (UNII: RHO26O1T9V) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CITRATE16 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    Coloryellow (Pale Yellow) Scoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-795-5430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/14/2023
    Labeler - PureTek Corporation (785961046)
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