Label: FOLIVANE-OB- ferrous fumarate, iron, ascorbic acid, folic acid, thiamine mononitrate, riboflavin, niacin, calcium pantothenate, pyridoxine hydrochloride, biotin, cyanocobalamin, cupric sulfate, magnesium sulfate, manganese sulfate, and zinc sulfate capsule

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

Drug Label Information

Updated October 29, 2019

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

  • SUPPLEMENT FACTS

    Folivane-OB Supplement Facts Rev. 092019

    Other Ingredients: Capsule (Hypromellose, Titanium Dioxide, FD&C Blue #1, FD&C Red #40) Microcrystalline Cellulose, Magnesium Stearate, and Fumed Silica.


    Folivane™-OB is a prescription prenatal supplement designed to improve the nutritional status of women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Folivane™-OB may also be used to improve the nutritional status of women. DO NOT ADMINISTER TO CHILDREN UNDER THE AGE OF 12.

  • CONTRAINDICATIONS

    Folivane™-OB is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemia. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

  • WARNING

     WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUTOF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

  • PRECAUTION

    General

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia assessment, such that hematologic remission can occur while neurological manifestations remain progressive.

    Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic tests (e.g. troponin) and hormone test, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.

    Pediatric Use

    Safety and effectiveness of this product have not been established in pediatric patients.

    Geriatric Use

    Safety and effectiveness of this product have not been established in elderly patients.

  • DRUG INTERACTIONS

    Folivane™-OB is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g. Aspirin, Heparin, Clopidogrel).

  • ADVERSE REACTIONS

    Folic Acid

    Allergic sensitization have been reported following both oral and parenteral administration of folic acid.

    Ferrous Fumarate

    Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Folivane™-OB after meals may control occasional G.I. disturbances. Folivane™-OB is best absorbed when taken at bedtime.

  • OVERDOSAGE

    Acute overdosage of iron may cause abdominal pain, nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other more chronic symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. Toxic effects are seen at 10-20 mg/kg elemental iron. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Folivane™-OB should be stored beyond the reach of children to prevent against accidental iron poisoning.


    Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

  • DESCRIPTION

    Folivane™-OB are blue opaque capsules imprinted with “T535” in white ink on both cap and body.

  • DIRECTIONS FOR USE

    One (1) capsule daily, between meals, or as prescribed by a physician.  Do not exceed recommended dosage.

  • HOW SUPPLIED

    Folivane™-OB is dispensed in child-resistant bottles of 30 capsules.

    Product Code: 13811-535-30

  • STORAGE

    Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.

    KEEP OUT OF REACH OF CHILDREN.

  • HEALTH CLAIM

    For use on the order of a healthcare practitioner.


    Call your doctor about side effects. To report side effects, call Trigen Laboratories at 1-877-482-3788 or FDA at 1-800-FDA-1088.


    Customer Service: 1-877-482-3788                                                                                                              Rev. 09/2019


    Manufactured for:
    Trigen Laboratories, LLC
    Bridgewater, NJ 08807

    Trigen logo

  • PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

    13811-535-30

    Folivane™-OB
    with Ascorbic Acid Precursors

    PRENATAL MULTIVITAMIN SUPPLEMENT

    30 CAPSULES

    Folivane-OB Bottle Label Rev. 09/2019
  • INGREDIENTS AND APPEARANCE
    FOLIVANE-OB 
    ferrous fumarate, iron, ascorbic acid, folic acid, thiamine mononitrate, riboflavin, niacin, calcium pantothenate, pyridoxine hydrochloride, biotin, cyanocobalamin, cupric sulfate, magnesium sulfate, manganese sulfate, and zinc sulfate capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-535
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Ferrous Fumarate (UNII: R5L488RY0Q) (Ferrous Cation - UNII:GW89581OWR) Ferrous Cation42.5 mg
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron42.5 mg
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid210 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine5 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin5 mg
    Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin20 mg
    Calcium Pantothenate (UNII: 568ET80C3D) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Cation7 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride25 mg
    Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin300 ug
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin10 ug
    Cupric Sulfate (UNII: LRX7AJ16DT) (Cupric Cation - UNII:8CBV67279L) Cupric Cation800 ug
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (Magnesium Cation - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE6.9 mg
    Manganese Sulfate (UNII: W00LYS4T26) (Manganese Cation (2+) - UNII:H6EP7W5457) Manganese Cation (2+)1.3 mg
    Zinc Sulfate (UNII: 89DS0H96TB) (Zinc Cation - UNII:13S1S8SF37) Zinc Cation18.2 mg
    Inactive Ingredients
    Ingredient NameStrength
    Hypromelloses (UNII: 3NXW29V3WO)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:13811-535-3030 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT01/01/2010
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    imprint
    scoring1
    shape
    size (solid drugs)22 mm
    Labeler - Trigen Laboratories, LLC (830479668)