Label: PRENATAL, DHA- thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, choline bitartrate, and doconexent 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 May 14, 2019

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

  • Description:

    Prenatal + DHA™ includes a light pink coated oblong-shaped tablet with “P658” debossed on one side of the tablet and a natural DHA softgel containing a pale orange oil.

    Each tablet contains:

    Vitamin B1 (Thiamin Mononitrate)3 mg
    Vitamin B2 (Riboflavin)3 mg
    Vitamin B6 (Pyridoxine HCl)50 mg
    Vitamin B12 (Cyanocobalamin)8 mcg
    Vitamin C (Ascorbic acid)120 mg
    Niacin (Niacinamide)20 mg
    Folic acid1 mg
    Iron (Ferrous Fumarate)27 mg
    Calcium (Calcium Carbonate)200 mg
    Vitamin D3 (Cholecalciferol)10.3 mcg
    Vitamin E (DL-Alpha Tocopheryl Acetate)27 mg
    Iodine (Potassium Iodide)150 mcg
    Zinc (Zinc Oxide)15 mg
    Choline Bitartrate55 mg

    Tablet Inactive Ingredients:

    Maltodextrin, Microcrystalline Cellulose, Croscarmellose Sodium, Modified Starch, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Citric Acid, Talc, Silica, Stearic Acid, Magnesium Stearate, Calcium Sulfate, Bovine Gelatin Hydrolyzed, Sucrose, Dicalcium Phosphate, Corn Starch, Silicon Dioxide, FD&C Red #40/Allura Red AC Aluminum Lake, Partially Hydrogenated Soybean Oil, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, FD&C Blue #1/Brilliant Blue FCF Aluminum Lake.

    Each DHA softgel contains:

    DHA is an omega-3 fatty acid. The DHA in Prenatal + DHA™ is derived from Algal Oil (C.cohnii). 625 mg of Algal Oil is equivalent to 250 mg of DHA.

    Other ingredients in the DHA softgel: Gelatin, High Oleic Sunflower Oil, Glycerin, Ascorbyl Palmitate, Tocopherols,  Polysorbate 80.

    Docosahexaenoic Acid (DHA) from Algal Oil250 mg

  • indications and Usage:

    Prenatal + DHA™ is indicated to provide vitamin/mineral and DHA omega-3 fatty acid supplement to women throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Prenatal + DHA™ may be beneficial in improving the nutritional status of women prior to conception.

  • Contraindications:

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

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

  • Warnings:

    Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

  • Precautions:

    Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

  • Adverse Reactions:

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

  • DOSAGE AND ADMINISTRATION

    One Prenatal + DHA™ tablet and one Prenatal + DHA™ softgel daily or as directed by a physician.

  • How Supplied

    Prenatal + DHA™ is supplied as six child-resistant blister cards containing 5 Prenatal + DHA™ tablets and 5 Prenatal + DHA™ softgels each - NDC 59088-096-58. 

  • Storage

    Do not use if blister seal is broken.
    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Excursions permitted to 15° to 30ºC (59° to 86°F).

    To report a serious adverse event or to obtain product information, contact 877-921-7873

    Manufactured in the USA by:
    PureTek Corporation 

    San Fernando, CA 91340

    For questions or information 

    call toll-free: 877-921-7873

  • PRINCIPAL DISPLAY PANEL - Carton 

    image description

  • INGREDIENTS AND APPEARANCE
    PRENATAL, DHA 
    thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, choline bitartrate, and doconexent kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-096
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-096-586 in 1 CARTON08/10/2017
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 15 BLISTER PACK
    Part 2
    Part 1 of 2
    PRENATAL 
    thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, niacin, folic acid, ferrous fumarate, calcium carbonate, cholecalciferol, vitamin e acetate, potassium iodide, zinc oxide, and choline bitartrate tablet
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE3 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE50 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN8 ug
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN20 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION200 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10.3 ug
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL27 ug
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION150 ug
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 mg
    CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y) (CHOLINE - UNII:N91BDP6H0X) CHOLINE55 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CALCIUM SULFATE (UNII: WAT0DDB505)  
    GELATIN (UNII: 2G86QN327L)  
    SUCROSE (UNII: C151H8M554)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorpink (P658, light, coated) Scoreno score
    ShapeCAPSULE (oblong) Size19mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other
    Part 2 of 2
    DHA 
    doconexent capsule, liquid filled
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT250 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColororangeScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other08/10/2017
    Labeler - PureTek Corporation (785961046)