TRICARE PRENATAL DHA ONE- fish oil, doconexent, icosapent, thiamine mononitrate, riboflavin, inositol niacinate, pyridoxine hydrochloride, cyanocobalamin, folic acid, ascorbic acid, cholecalciferol, d-alpha-tocopherol, biotin, ferrous fumarate, zinc sulfate monohydrate, cupric sulfate anhydrous, docusate sodium capsule, gelatin coated

TRICARE PRENATAL DHA ONE by

Drug Labeling and Warnings

TRICARE PRENATAL DHA ONE by is a Prescription medication manufactured, distributed, or labeled by Medecor Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Description:

Each purple softgel contains:

• Fish Oil Concentrate 10/50 TG: 500 mg
• DHA: 215 mg
• EPA: 45 mg
• 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
• Iron (Ferrous Fumarate): 27 mg
• Zinc (Zinc Sulfate Monohydrate): 10 mg
• Copper (Cupric Sulfate Anhydrous): 2 mg
• Docusate Sodium: 25 mg

INACTIVE INGREDIENTS:

Gelatin, Glycerol, Hydrogenated Vegetable Oil, Purified Water, Yellow Beeswax, Lecithin, Colloidal Anhydrous Silica, Ethanol, Natural Lime Oil Ordinary 479208/ARTG 1258, Cochineal C175470, Lemon Oil, Titanium Dioxide, Polysorbate 80, Brilliant Blue FCF C142090

CONTRAINDICATIONS:

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

BOXED WARNING

(What is this?)

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.

GENERAL PRECAUTIONS

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® Multivitamin/Mineral Softgels for oral administration are supplied as purple softgels, imprinted in gray ink: TriCare DHA 401 in a child-resistant plastic bottle of 30 softgels. (NDC: 67112-401-30).

BOXED WARNING

(What is this?)

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.

STORAGE AND HANDLING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRICARE PRENATAL DHA ONE 
fish oil, doconexent, icosapent, thiamine mononitrate, riboflavin, inositol niacinate, pyridoxine hydrochloride, cyanocobalamin, folic acid, ascorbic acid, cholecalciferol, d-alpha-tocopherol, biotin, ferrous fumarate, zinc sulfate monohydrate, cupric sulfate anhydrous, docusate sodium capsule, gelatin coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 67112-401
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FISH OIL (UNII: XGF7L72M0F) (FISH OIL - UNII:XGF7L72M0F)	FISH OIL	500 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	215 mg
ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA)	ICOSAPENT	45 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE MONONITRATE	3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	3.4 mg
INOSITOL NIACINATE (UNII: A99MK953KZ) (INOSITOL NIACINATE - UNII:A99MK953KZ)	INOSITOL NIACINATE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	25 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	100 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	60 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	800 [iU]
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	30 [iU]
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	300 ug
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	27 mg
ZINC SULFATE MONOHYDRATE (UNII: PTX099XSF1) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 mg
CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	2 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	25 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALCOHOL (UNII: 3K9958V90M)
LIME OIL (UNII: UZH29XGA8G)
COCHINEAL (UNII: TZ8Z31B35M)
LEMON OIL (UNII: I9GRO824LL)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	purple	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	TriCare;DHA;401
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67112-401-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2012
2	NDC: 67112-401-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2012

Labeler - Medecor Pharma, LLC (830621046)

Registrant - Medecor Pharma, LLC (830621046)