Label: TRICARE PRENATAL- ascorbic acid, cholecalciferol, dl-.alpha.-tocopherol acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric sulfate tablet, coated

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

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Drug Label Information

Updated January 17, 2012

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  • DESCRIPTION:

    Each light blue film coated tablet contains:

    Vitamin C (Ascorbic Acid)
    100 mg
    Vitamin D-3 (Cholecalciferol)
    400 IU
    Vitamin E (dl-Alpha Tocopheryl Acetate)
    30 IU
    Vitamin B-1 (Thiamine HCl)
    1.6 mg
    Vitamin B-2 (Riboflavin)
    1.6 mg
    Niacin (Niacinamide)
    20 mg
    Vitamin B-6 (Pyridoxine HCl)
    3.1 mg
    Folic Acid
    1 mg
    Vitamin B-12 (Cyanocobalamin)
    12 mcg
    Calcium (Calcium Carbonate)
    200 mg
    Iron (Ferrous Fumarate)
    27 mg
    Zinc (Zinc Oxide)
    10 mg
    Copper (Cupric Sulfate)
    2 mg
  • INDICATIONS AND USAGE:

    TriCare® Prenatal tablets are indicated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother.  It is also useful for improving nutritional status prior to conception.

  • CONTRAINDICATIONS:

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

  • BOXED WARNING (What is this?)

    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 right away.

  • GENERAL PRECAUTIONS

    Folic acid alone is improper therapy in the treatment of prenicious anemia and other megaloblastic anemias where vitamin B-12 is deficient.

  • PRECAUTIONS:

    Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

  • ADVERSE REACTIONS:

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

  • DOSAGE AND ADMINISTRATION:

    One tablet daily or as directed by a physician.

  • HOW SUPPLIED:

    TriCare® Prenatal Multivitamin/Mineral Tablets for oral administration are supplied as light blue, film coated tablets, debossed MP 101 with a partial bisect through the tablets on one side.  In a child resistant plastic bottle of 100 tablets (NDC 67112-101-00).

  • OTHER INGREDIENTS:

    acacia, croscarmellose sodium, dicalcium phosphate, FD&C blue #1 Lake, FD&C blue #2 Lake, FD&C red #40 Lake, gelatin, hypromellose, magnesium silicate, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyvinylpyrrolidone, silica, sodium lauryl sulfate, soy polysaccharide, stearic acid, titanium dioxide, and triacetin.

  • STORAGE AND HANDLING

    Store at controlled room temperature, 15o-30oC (59o-86oF)

    NOTICE:  Contact with moisture may produce surface discoloration or erosion of the tablet.

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

    Marketed by Medecor Pharma LLC, Baton Rouge, LA  70802

  • PRINCIPAL DISPLAY PANEL:


    TriCare Prenatal Label


    NDC 67112-101-00

    TriCare

    PRENATAL

    Multivitamin/Mineral

    Film Coated Tablet

    Complete Nutritional Needs of Women

    100 TABLETS

    • Preconception
    • Pregnancy
    • Postnatal
    Rx Only
  • INGREDIENTS AND APPEARANCE
    TRICARE PRENATAL 
    ascorbic acid, cholecalciferol, dl-.alpha.-tocopherol acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric sulfate tablet, coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67112-101
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL ACETATE, DL- - UNII:WR1WPI7EW8) .ALPHA.-TOCOPHEROL ACETATE, DL-30 [iU]
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE - UNII:X66NSO3N35) THIAMINE HYDROCHLORIDE1.6 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.6 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE3.1 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (IRON - UNII:E1UOL152H7) FERROUS FUMARATE27 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE10 mg
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC SULFATE2 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Colorblue (light blue) Score2 pieces
    ShapeOVALSize19mm
    FlavorImprint Code MP;101
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67112-101-00100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/11/2002
    Labeler - Medecor Pharma, LLC (830621046)
    Registrant - Medecor Pharma, LLC (830621046)
    Establishment
    NameAddressID/FEIBusiness Operations
    Catalent Australia PTY LTD753617638manufacture