Label: COMPLETENATE CHEWABLE- .beta.-carotene, ascorbic acid, sodium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and ferrous fumarate tablet

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

Drug Label Information

Updated December 29, 2021

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

  • SUPPLEMENT FACTS

    CompleteNate Chewable

    Other Ingredients: Sorbitol, Sucrose, Natural Orange Flavor, Orange Juice Powder, Magnesium Stearate, Stearic Acid, Gelatin, Stevia, Fumed Silica.

    CompleteNate Chewable tablets are formulated to provide vitamin and mineral supplementation throughout pregnancy and during postnatal period, for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.

  • CONTRAINDICATIONS

    CompleteNate Chewable should not be used by patients with a known hypersensitivity to any of the listed ingredients. All iron compounds are contraindicated in patients with hemochromatosis, hemosiderosis, or hemolytic anemias.

  • 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

    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, in that hematologic remission can occur while neurological manifestations remain progressive.


    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

    CompleteNate Chewable Tablets 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 sensitizations 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 and physician encouragement. Although the absorption of iron is best when taken between meals, occasional G.I. disturbances may be controlled by giving CompleteNate Chewable shortly after meals.


    The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

  • OVERDOSAGE

    Iron is toxic. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. CompleteNate Chewable should be stored beyond the reach of children to protect against accidental iron poisoning.

  • DESCRIPTION

    CompleteNate Chewable is an orange-flavored, round, speckled light brown tablet debossed with “TL014” on one side.

  • DIRECTIONS FOR USE

    Take one tablet by mouth daily or as directed by a physician.

  • HOW SUPPLIED

    CompleteNate Chewable is supplied in bottles of 90 tablets.

    PRODUCT CODE 13811-014-90

  • STORAGE

    Store at 20°-25°C (68°-77°F), relative humidity no higher than 65%; excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet. Dispense in a tight, light-resistant container with a child resistant closure as defined by the USP.

  • 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, LLC at 1-770-509-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


    PLR-CNC-00002-1                                          Rev. 12/2021

    Manufactured for:

     Trigen Laboratories, LLC                                                                                                                                           

    Alpharetta, GA 30005

    www.trigenlab.com

     TRIGEN LOGO

  • PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

    13811-014-90

    90 Tablets

    CompleteNate
    Chewable

    Chewable Prenatal Multivitamin Tablet with Iron

    TRIGEN
    LABORATORIES

    CompleteNate Chewable Tablets BL Rev. 12/2021
  • INGREDIENTS AND APPEARANCE
    COMPLETENATE CHEWABLE 
    .beta.-carotene, ascorbic acid, sodium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and ferrous fumarate tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-014
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE1000 [iU]
    ascorbic acid (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ascorbic acid48 mg
    sodium ascorbate (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID72 mg
    cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) cholecalciferol400 [iU]
    .alpha.-tocopherol acetate, dl- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-11 [iU]
    thiamine mononitrate (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE2 mg
    riboflavin (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) riboflavin3 mg
    niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) niacinamide20 mg
    pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) pyridoxine Hydrochloride10 mg
    folic acid (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) folic acid1 mg
    cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) cyanocobalamin12 ug
    ferrous fumarate (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION29 mg
    Inactive Ingredients
    Ingredient NameStrength
    sorbitol (UNII: 506T60A25R)  
    sucrose (UNII: C151H8M554)  
    magnesium stearate (UNII: 70097M6I30)  
    stearic acid (UNII: 4ELV7Z65AP)  
    gelatin (UNII: 2G86QN327L)  
    stevia rebaudiuna leaf (UNII: 6TC6NN0876)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ORANGE (UNII: 5EVU04N5QU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:13811-014-9090 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT07/01/2010
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    flavor
    imprint
    scoring1
    shape
    size (solid drugs)12 mm
    Labeler - Trigen Laboratories, LLC (830479668)