Label: TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM- 18 essential vitamins and minerals, ultra pure dha kit

  • NDC Code(s): 67112-201-60, 67112-502-60, 67112-802-60
  • Packager: Medecor Pharma, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated May 18, 2016

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  • STATEMENT OF IDENTITY

    INDICATIONS AND USAGE: TriCare Prenatal™ Chewable
    Tablets with Twist-off DHA Softgels 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.
    NOTICE: Contact with moisture may produce surface
    discoloration or erosion of the tablets and twist-off softgels.
    ADVERSE REACTIONS: Allergic sensitization has been
    reported following both oral and parenteral administration
    of folic acid.
    DOSAGE: Two (2) chewable tablets and two (2) twist-off
    softgels daily or as directed by a physician.
    ADMINISTRATION: Chew tablets before swallowing. Twist
    small end off from softgel and squeeze contents directly into
    mouth or into juice to drink. Daily dosage should be taken
    with food.
    HOW SUPPLIED: Child-resistant, blister pack of two (2) white
    tablets and two (2) purple twist-off softgels.
    Each tablet is embossed MP 201.
    Each Twist-off softgel is marked MP 802.
    (NDC 67112-502-60)
    Store at controlled room temperature, 15º-30ºC (59º-86ºF).
    TO REPORT a serious adverse event or obtain product
    information, call 877-803-8235.
    KEEP THIS AND ALL DRUGS OUT OF THE REACH
    OF CHILDREN.
    Marketed by: Medecor Pharma, LLC, Baton Rouge, LA
    Patent Pending

  • PRINCIPAL DISPLAY PANEL

    Chewable Retail Box

    Chewable Tablet 1_LBL

    Twist-Off DHA Softgel_LBL

  • INGREDIENTS AND APPEARANCE
    TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM 
    18 essential vitamins and minerals, ultra pure dha kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67112-502
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67112-502-601 in 1 BOX05/10/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE
    Part 21 BOTTLE
    Part 1 of 2
    TRICARE PRENATAL TWIST-OFF DHA SOFT  QUICK DISSOLVE
    dha, epa, other omega-3s capsule, gelatin coated
    Product Information
    Item Code (Source)NHRIC:67112-802
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT150 
    ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT37.5 
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S) OMEGA-3 FATTY ACIDS75 
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    COCHINEAL (UNII: TZ8Z31B35M)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    Product Characteristics
    ColorpurpleScoreno score
    ShapeCAPSULESize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:67112-802-601 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement05/10/2016
    Part 2 of 2
    TRICARE PRENATAL  QUICK DISSOLVE
    18 essential vitamins and minerals tablet, chewable
    Product Information
    Item Code (Source)NHRIC:67112-201
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID30 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL SUCCINATE, D-15 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.25 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN.85 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE10 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE2.5 mg
    LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID1 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN.125 mg
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN.150 mg
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID5 mg
    FERRIC PYROPHOSPHATE (UNII: QK8899250F) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION4.5 mg
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC7 mg
    SODIUM SELENITE (UNII: HIW548RQ3W) (SELENITE ION - UNII:KXO0259XJ1) SODIUM SELENITE.0325 mg
    COPPER GLUCONATE (UNII: RV823G6G67) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1 mg
    MANGANESE CITRATE DECAHYDRATE (UNII: 4Z2OA6A13N) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE CITRATE DECAHYDRATE1 mg
    CHROMIC CHLORIDE CR-51 (UNII: U4M5Y13FGM) (CHROMIUM CR-51 - UNII:9QAU17N705) CHROMIC CHLORIDE CR-51.060 mg
    SODIUM MOLYBDATE (UNII: 948QAQ08I1) (MOLYBDATE ION - UNII:O0L10E6352) SODIUM MOLYBDATE.0375 mg
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A)  
    CROSPOVIDONE (UNII: 68401960MK)  
    POLYVINYL ACETATE (UNII: 32K497ZK2U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POVIDONE (UNII: FZ989GH94E)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:67112-201-601 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement03/21/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/10/2016
    Labeler - Medecor Pharma, LLC (830621046)