Label: TRINATAL RX 1- acetate ion, .beta.-carotene, cholecalciferol, .alpha.-tocopherol acetate, dl-, ascorbic acid, folic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, magnesium oxide, ferrous fumarate, cupric oxide, and zinc oxide tablet, film coated

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

Drug Label Information

Updated January 7, 2022

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

  • SUPPLEMENT FACTS

    Trinatal RX 1 Supplement Facts Table

    Other Ingredients: Microcrystalline cellulose, coating (hypromellose, titanium dioxide, polyvinyl alcohol, polyethylene glycol, talc) tripotassium citrate, croscarmellose sodium, citric acid, povidone K30, acacia, stearic acid, magnesium stearate, fumed silica.

    Trinatal Rx 1 tablets help assure an adequate intake of the vitamins and minerals listed. Folate supplementation may be recommended for individuals who have higher-than-normal demands for folate such as pregnant women.

  • CONTRAINDICATIONS

    Supplemental vitamins and minerals should not be prescribed for patients with hemochromatosis or Wilson’s disease.

  • WARNINGS

    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.

  • PRECAUTIONS

    General: 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 0.1 mg daily may obscure pernicious anemia assessment, such that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia. The calcium content should be considered before prescribing for patients with history of kidney stones. Do not exceed the recommended dose.

    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 in pediatric patients have not been established.

    Geriatric Use: Safety and effectiveness in elderly patients have not been established.

  • DRUG INTERACTIONS

    Trinatal Rx 1 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

    Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

  • DESCRIPTION

    Trinatal Rx 1 is an oval shaped, white film-coated tablet debossed "TL388".

  • DIRECTIONS FOR USE

    Take One (1) tablet daily or as prescribed by a physician.

  • HOW SUPPLIED

    Trinatal Rx 1 is supplied in bottles of 100 tablets.

    Product Code: 13811-007-10

  • STORAGE

    Store at 20°-25°C (68°-77°F), excursion 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.

  • HEALTH CLAIM

    KEEP OUT OF REACH OF CHILDREN.

    For use on the order of a healthcare practitioner.

    Call your doctor about side effects. To report side effects, call Trigen Laboratories at 1-770-509-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    PLR-TRIRX-00001-1                                                   Rev. 12/2021

    Manufactured for:

    Trigen Laboratories, LLC

    Alpharetta, GA 30005

    Trigen Logo
  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    13811-007-10

    100 Tablets

    Trinatal Rx 1
    (one tablet daily)

    Prenatal Multivitamin/Multimineral Tablet

    TRIGEN
    LABORATORIES

    Trinatal Rx 1 BL Rev. 12/2021
  • INGREDIENTS AND APPEARANCE
    TRINATAL RX 1 
    acetate ion, .beta.-carotene, cholecalciferol, .alpha.-tocopherol acetate, dl-, ascorbic acid, folic acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, calcium pantothenate, calcium carbonate, magnesium oxide, ferrous fumarate, cupric oxide, and zinc oxide tablet, film coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    acetate ion (UNII: 569DQM74SC) (acetate ion - UNII:569DQM74SC) acetate ion3600 [iU]
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE400 [iU]
    cholecalciferol (UNII: 1C6V77QF41) (cholecalciferol - UNII:1C6V77QF41) cholecalciferol400 [iU]
    .alpha.-tocopherol acetate, dl- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-15 [iU]
    ascorbic acid (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ascorbic acid80 mg
    folic acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) folic acid1 mg
    thiamine mononitrate (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
    riboflavin (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) riboflavin1.6 mg
    niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) niacinamide17 mg
    pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) pyridoxine Hydrochloride4 mg
    cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) cyanocobalamin2.5 ug
    biotin (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) biotin30 ug
    calcium pantothenate (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID7 mg
    calcium carbonate (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) calcium carbonate200 mg
    magnesium oxide (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) magnesium oxide100 mg
    ferrous fumarate (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION60 mg
    cupric oxide (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION3 mg
    zinc oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) zinc oxide25 mg
    Inactive Ingredients
    Ingredient NameStrength
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    hypromelloses (UNII: 3NXW29V3WO)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    talc (UNII: 7SEV7J4R1U)  
    potassium citrate anhydrous (UNII: 86R1NVR0HW)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    povidone K30 (UNII: U725QWY32X)  
    acacia (UNII: 5C5403N26O)  
    stearic acid (UNII: 4ELV7Z65AP)  
    magnesium stearate (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:13811-007-10100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT03/01/2009
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    imprint
    scoring1
    shape
    size (solid drugs)19 mm
    Labeler - Trigen Laboratories, LLC (830479668)