Complete Natal DHA: Package Insert and Label Information

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

SUPPLEMENT FACTS

Complete Natal DHA Supplement Facts Table
(click image for full-size original)

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 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 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 1-770-509-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PLR-COMNDHA-00001-1 Rev. 01/2022

Manufactured for:

Trigen Laboratories, LLC

Alpharetta, GA 30005

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 Rev. 01/2022
(click image for full-size original)
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 Item Code (Source) NDC:13811-010
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13811-010-30 1 KIT in 1 CARTON None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETA CAROTENE (BETA CAROTENE) BETA CAROTENE 3000 [iU]
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 120 mg
Cholecalciferol (Cholecalciferol) Cholecalciferol 400 [iU]
.Alpha.-Tocopherol Acetate, DL- (.Alpha.-Tocopherol, DL-) .Alpha.-Tocopherol, DL- 30 mg
Thiamine Mononitrate (Thiamine Ion) Thiamine 1.8 mg
Riboflavin (Riboflavin) Riboflavin 4 mg
Niacinamide (Niacinamide) Niacinamide 20 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 12 ug
Calcium Carbonate (Calcium Cation) Calcium Carbonate 200 mg
Ferrous Bisglycinate (Ferrous Cation) Ferrous Cation 29 mg
Magnesium Oxide (Magnesium Cation) Magnesium Oxide 25 mg
Zinc Oxide (Zinc Oxide) Zinc Oxide 25 mg
Cupric Oxide (Cupric Cation) Cupric Cation 2 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline
CASTOR OIL
Croscarmellose Sodium
Hypromelloses
Acacia
Citric Acid Monohydrate
Povidone K30
Magnesium Stearate
POLYETHYLENE GLYCOL, UNSPECIFIED
Stearic acid
Polysorbate 80
Product Characteristics
Color brown (Light brown and yellow speckled) Score no score
Shape OVAL Size 19mm
Flavor Imprint Code 1030
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 30 TABLET, FILM COATED in 1 BLISTER PACK None
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Doconexent (Doconexent) Doconexent 200 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN TYPE B BOVINE (200 BLOOM)
Glycerin
Water
.Alpha.-Tocopherol
Ethyl Vanillin
Product Characteristics
Color yellow (Pale yellow) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 30 CAPSULE in 1 BLISTER PACK None
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: 01/2022 Trigen Laboratories, LLC

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