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 
Trigen Laboratories, LLC

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Complete Natal DHA

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.

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.

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. 


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.

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).

ADVERSE REACTIONS

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

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.

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.

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

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.

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

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

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)

Revised: 10/2018
Document Id: 1c364fd1-1486-4f0e-8fad-c10647b197bb
Set id: da53ce22-b0a3-4c91-94df-e03693aec841
Version: 2
Effective Time: 20181031
 
Trigen Laboratories, LLC