Label: TRICARE PRENATAL COMPLEAT- essential fatty acids, multivitamins, minerals kit

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 11, 2016

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

  • ACTIVE INGREDIENT

    DESCRIPTION: Each light blue film coated tablet contains:
    Vitamins

    • Vitamin C (Ascorbic Acid) 100 mg 167%
    • Vitamin D-3 (Cholecalciferol) 400 I.U. 100%
    • Vitamin E (dl-Alpha Tocopheryl Acetate) 30 I.U. 100%
    • Vitamin B-1 (Thiamine HCL) 1.6 mg. 94%
    • Vitamin B-2 (Riboflavin) 1.6 mg. 80%
    • Niacin (Niacinamide) 20 mg. 100%
    • Vitamin B-6 (Pyridoxine HCL) 3.1 mg. 124%
    • Folic Acid 1 mg. 125%
    • Vitamin B-12 (Cyanocobalamin) 12 mcg. 150%

    Minerals

    • Calcium (Calcium Carbonate) 200 mg. 15%
    • Iron (Ferrous Fumarate) 27 mg. 150%
    • Zinc (Zinc Oxide) 10 mg. 67%
    • Copper (Cupric Sulfate) 2 mg. 100%

    DESCRIPTION: Each pink chewable softgel contains:
    Essential Fatty Acids
    Fish Oil Concentrate

    • DHA (Docosahexaenoic acid) 135.0 mg
    • EPA (Eicosapentaenoic acid) 33.80 mg
    • Other Omega-3’s 71.20 mg
  • INACTIVE INGREDIENT

    DESCRIPTION: Each light blue film coated tablet contains:

    OTHER INGREDIENTS: Aerosil 200V, carnauba wax, FD&C blue #1 Lake, FD&C blue #2 Lake, FD&C red#40 Lake, Kollidon® 30,
    magnesium stearate, microcrystalline cellulose, Opadry, Polyplasdone® XL, sodium starch glycolate.

    DESCRIPTION: Each pink chewable softgel contains:

    OTHER INGREDIENTS: Highly refined and concentrated Omega-3 Fish Oil (Tuna) capsule (gelatin, potato starch, cochineal C175470,
    iron oxide black C177499, titanium dioxide), coconut oil-fractionated, lecithin, natural vitamin E (d-aplha -Tocopherol
    3.22 mg as vitamin E preparation USP), TS- 12550/ ARTG 13165, sucralose, xylitol (this material contains galactose, glucose,
    sucrose, invert sugar, mannitol and sorbitol) citric acid-anhydrous, orange oil, forest fruits flavour 174289941/ARTG-11546.

  • PRINCIPAL DISPLAY PANEL

    Compleat Rx Box_FR

    Compleat Rx Box_BK

    Compleat Rx Box_S1

    TriCare-Prenatal-Compleat_67112-601-30_Label

    TriCare-Prenatal-Compleat_67112-701-30

  • INGREDIENTS AND APPEARANCE
    TRICARE PRENATAL COMPLEAT 
    essential fatty acids, multivitamins, minerals kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67112-501
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67112-501-311 in 1 BOX03/21/2013
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE
    Part 21 BOTTLE
    Part 1 of 2
    TRICARE PRENATAL COMPLEAT  DHA ONE
    essential fatty acids capsule, gelatin coated
    Product Information
    Item Code (Source)NDC:67112-601
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT135 mg
    GONDOIC ACID (UNII: UDX6WPL94T) (GONDOIC ACID - UNII:UDX6WPL94T) GONDOIC ACID33.8 mg
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS71.2 mg
    Inactive Ingredients
    Ingredient NameStrength
    FISH OIL (UNII: XGF7L72M0F)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) 3.2 mg
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeCAPSULESize21mm
    FlavorImprint Code TriCare;DHA;401
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67112-601-301 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/21/2013
    Part 2 of 2
    TRICARE PRENATAL COMPLEAT  MULTIVITAMIN MINERAL
    multivitamins, minerals tablet, coated
    Product Information
    Item Code (Source)NDC:67112-701
    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, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 [iU]
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE ION1.6 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 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg
    CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
    Product Characteristics
    ColorblueScore2 pieces
    ShapeOVALSize19mm
    FlavorImprint Code MP;101
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67112-701-301 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/21/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/21/2013
    Labeler - Medecor Pharma, LLC (830621046)