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Tricare Prenatal DHA ONE

Generic name: prenatal multi-vitamin / mineral
Dosage form: softgel
Drug class: Iron products, Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Nov 1, 2020.

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.

Description:

Each purple softgel contains:

Essential Fatty Acids
Fish Oil Concentrate 10/50 TG 500 mg
DHA 215 mg
EPA 45 mg
Vitamins
Vitamin B-1 (Thiamine Nitrate) 3 mg
Vitamin B-2 (Riboflavin) 3.4 mg
Vitamin B-3 (Inositol Nicotinate) 20 mg
Vitamin B-6 (Pyridoxine Hydrochloride) 25 mg
Vitamin B-12 (Cyanocobalamin) 100 mcg
Folic Acid 1 mg
Vitamin C (Ascorbic Acid) 60 mg
Vitamin D3 (Cholecalciferol) 800 IU
Vitamin E (d-alpha-Tocopherol) 30 IU
Biotin 300 mcg
Minerals
Iron (Ferrous Fumarate) 27 mg
Zinc (Zinc Sulfate Monohydrate) 10 mg
Copper (Cupric Sulfate Anhydrous) 2 mg

Other Active Ingredients:

Docusate Sodium (with 15% sodium benzoate)

25 mg

INACTIVE INGREDIENTS:

Gelatin Capsule (Bovine Gelatin, Glycerin, Sorbitol Sorbitan Solution, Purified Water, Titanium Dioxide, FD&C Red #40, FD&C Red #3, FD&C Blue #1, Yellow Beeswax, Soy Lecithin

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. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B-12 is deficient.

PRECAUTIONS:

Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS:

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

DOSAGE AND ADMINISTRATION:

One softgel daily or as directed by a physician.

HOW SUPPLIED:

TriCare Prenatal™ DHA ONE® RX Multivitamin/Mineral Softgels for oral administration are supplied as purple softgels, imprinted in white ink: DHA 402 in a child-resistant plastic bottle of 30 softgels. (NDC 67112-402-30).

WARNING:

Ingestion of more than 3 grams of Omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking aniticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

NOTICE: Contact with moisture may produce surface discoloration or erosion of the softgel.

Store at controlled room temperature of: 20o-25oC (68o-77oF).

Excursions permitted to 15o-30oC (59o-86oF).

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Marketed by Medecor Pharma LLC, Baton Rouge, LA

Tricare Prenatal DHA ONE RX MULTIVITAMIN
fish oil, dha, epa, vitamins b-1, b-2, b-3, b-6, b-12, c, d3, e, biotin, iron, zinc, copper, iodine, docusate sodium capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67112-402
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FISH OIL (FISH OIL) FISH OIL 500 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 215 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 45 mg
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE MONONITRATE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
INOSITOL NIACINATE (INOSITOL NIACINATE) INOSITOL NIACINATE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 100 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 800 [iU]
.ALPHA.-TOCOPHEROL, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 30 [iU]
BIOTIN (BIOTIN) BIOTIN 300 ug
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 27 mg
ZINC SULFATE MONOHYDRATE (ZINC CATION) ZINC CATION 10 mg
CUPRIC SULFATE ANHYDROUS (CUPRIC CATION) CUPRIC CATION 2 mg
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 150 ug
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 25 ug
Inactive Ingredients
Ingredient Name Strength
SODIUM BENZOATE
GELATIN
GLYCERIN
SORBITOL
WATER
TITANIUM DIOXIDE
FD&C RED NO. 40
FD&C RED NO. 3
FD&C BLUE NO. 1
YELLOW WAX
LECITHIN, SOYBEAN
Product Characteristics
Color purple Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code DHA402
Contains
Packaging
# Item Code Package Description
1 NDC:67112-402-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/15/2019
Labeler - Medecor Pharma, LLC (830621046)
Registrant - Medecor Pharma, LLC (830621046)
Medecor Pharma, LLC