Label: COMPLETE NATAL DHA- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopheryo acetate, dl, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, magnesium oxide, zinc oxide, cupric oxide, and doconexent

  • NDC Code(s): 13811-010-30
  • Packager: Trigen Laboratories, LLC
  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated October 31, 2018

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SUPPLEMENT FACTS

    Complete Natal DHA Supplement Facts Table

    Other Ingredients:

    Tablets: Microcrystalline Cellulose, Croscarmellose Sodium, Tripotassium Citrate, Coating (Hypromellose, Polyethylene Glycol, Polysorbate 80, Castor Oil), Acacia, Citric Acid, Povidone K30, Fumed Silica, Magnesium Stearate and Stearic Acid

    Soft gelatin capsules: Bovine Gelatin, Glycerin, Water, and Ethyl Vanillin.

    THIS PRODUCT CONTAINS SOY AND FISH OIL (ANCHOVIES & SARDINES).

    Complete Natal DHA is a multivitamin/multimineral and omega-3 fatty acid supplement indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the post-natal period for both lactating and non-lactating mothers.

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  • CONTRAINDICATIONS

    Supplemental vitamins and minerals should not be prescribed for patients with hemochromatosis or Wilson’s disease. This product is contraindicated in patients with known hypersensitivity to any of the ingredients including soy or fish oil.

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  • WARNINGS

    Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

    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. 


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  • PRECAUTIONS

    General: 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. Allergic sensitization has been reported following both oral and parenteral administration of folic acid. The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

    Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

    Geriatric Use: Safety and effectiveness in elderly populations have not been established.

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  • DRUG INTERACTIONS

    Complete Natal DHA 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).

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  • ADVERSE REACTIONS

    Adverse reactions with iron therapy are usually transient and may include constipation, diarrhea, nausea, vomiting, dark stool and abdominal pain.

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  • DESCRIPTION

    Complete Natal DHA tablets are clear coated, speckled light brown, oval tablets with debossed "01030" on one side. Complete Natal DHA soft gelatin capsules are oblong, clear transparent soft gel capsules containing a pale yellow oil/liquid.

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  • DIRECTIONS FOR USE

    Take one tablet and one soft gelatin capsule by mouth daily, or as prescribed by a physician. The tablet and soft gelatin capsule may be taken together or at different times of the day.

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  • HOW SUPPLIED

    Complete Natal DHA is supplied in a 30 day unit-of-use dispensing carton containing 6 blister cards of 5 tablets and 5 soft gelatin capsules each.

    Product Code: 13811-010-30

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  • STORAGE

    Store at 20°-25°C (68°-77°F), 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.

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  • 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 1-888-9-TRIGEN (1-888-987-4436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Customer Service: 1-888-987-4436

    Rev. 09/2018

    Manufactured for:

    Trigen Laboratories, LLC

    Bridgewater, NJ 08807

    www.trigenlab.com

    Trigen Logo

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  • PRINCIPAL DISPLAY PANEL - Kit Carton

    TRIGEN
    LABORATORIES

    13811-010-30

    Complete Natal DHA

    Prenatal Multivitamin/Multimineral Tablets and Omega-3 Fatty Acid Soft Gelatin Capsules

    30 Tablets and 30 Soft Gelatin Capsules

    (6 Unit-Dose Cards of 5 tablets and 5 soft gelatin capsules)

    Complete Natal DHA Carton

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  • INGREDIENTS AND APPEARANCE
    COMPLETE NATAL DHA 
    .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopheryo acetate, dl, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, magnesium oxide, zinc oxide, cupric oxide, and doconexent kit
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:13811-010
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:13811-010-30 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 BLISTER PACK 30 
    Part 2 1 BLISTER PACK 30 
    Part 1 of 2
    COMPLETE NATAL DHA 
    .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopheryo acetate, dl, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, magnesium oxide, zinc oxide, and cupric oxide tablet, film coated
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    .Beta.-Carotene (UNII: 01YAE03M7J) (.Beta.-Carotene - UNII:01YAE03M7J) .Beta.-Carotene 3000 [iU]
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 120 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 400 [iU]
    .Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8) (.Alpha.-Tocopherol, DL- - UNII:7QWA1RIO01) .Alpha.-Tocopherol, DL- 30 mg
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine 1.8 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 4 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide 20 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 25 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 12 ug
    Calcium Carbonate (UNII: H0G9379FGK) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Carbonate 200 mg
    Ferrous Bisglycinate (UNII: SFW1D987QV) (Ferrous Cation - UNII:GW89581OWR) Ferrous Cation 29 mg
    Magnesium Oxide (UNII: 3A3U0GI71G) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Oxide 25 mg
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 25 mg
    Cupric Oxide (UNII: V1XJQ704R4) (Cupric Cation - UNII:8CBV67279L) Cupric Cation 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Acacia (UNII: 5C5403N26O)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Povidone K30 (UNII: U725QWY32X)  
    Magnesium Stearate (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Stearic acid (UNII: 4ELV7Z65AP)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 06/01/2010
    Part 2 of 2
    COMPLETE NATAL DHA 
    doconexent capsule
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Doconexent (UNII: ZAD9OKH9JC) (Doconexent - UNII:ZAD9OKH9JC) Doconexent 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    GELATIN TYPE B BOVINE (200 BLOOM) (UNII: A7JR5F8DLH)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    Ethyl Vanillin (UNII: YC9ST449YJ)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 06/01/2010
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 06/01/2010
    Labeler - Trigen Laboratories, LLC (830479668)
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