TRICARE PRENATAL DHA ONE- multivitamin/mineral 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, Catalent Australia PTY LTD. 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

INDICATIONS AND USAGE:

TriCare® Prenatal DHA ONE® Multivitamin/Mineral softgels are indicated to provide multivitamin/mineral/essential fatty acid supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother.  It is also useful for improving nutritional status prior to conception.

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 90 softgels. (NDC: 67112-401-90).

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

TriCare® Prenatal

DHA ONE®

Multivitamin/Mineral

Softgel

ESSENTIAL NUTRITION FOR THE THREE

VITAL STAGES OF PREGNANCY

• Preconception
• Pregnancy
• Postnatal

NDC: 67112-401-90

Rx Only

INGREDIENTS AND APPEARANCE

TRICARE PRENATAL DHA ONE 
multivitamin/mineral 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 - UNII:X66NSO3N35)	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) (IRON - UNII:E1UOL152H7)	FERROUS FUMARATE	27 mg
ZINC SULFATE MONOHYDRATE (UNII: PTX099XSF1) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE MONOHYDRATE	10 mg
CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC SULFATE ANHYDROUS	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: 67112-401-90	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/13/2010

Labeler - Medecor Pharma, LLC (830621046)

Registrant - Medecor Pharma, LLC (830621046)

Establishment
Name	Address	ID/FEI	Business Operations
Catalent Australia PTY LTD		753617638	manufacture