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 
Medecor Pharma, LLC
Reference Label Set Id: 6464712a-b1a5-439f-88f4-49de1742f22f

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.

----------

TRICARE PRENATAL DHA ONE

Description:

Each purple softgel contains:

Essential Fatty Acids
Fish Oil Concentrate 10/50 TG500 mg
     DHA215 mg
     EPA45 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 Acid1 mg
Vitamin C (Ascorbic Acid)60 mg
Vitamin D3 (Cholecalciferol)800 IU
Vitamin E (d-alpha-Tocopherol)30 IU
Biotin300 mcg
Minerals
Iron (Ferrous Fumarate)27 mg
Zinc (Zinc Sulfate Monohydrate)10 mg
Copper (Cupric Sulfate Anhydrous)2 mg
Docusate Sodium25 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.

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® 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).

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

Medecor TriCare Prenatal DHA ONE Label

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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67112-401
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FISH OIL (UNII: XGF7L72M0F) (FISH OIL - UNII:XGF7L72M0F) FISH OIL500 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT215 mg
ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT45 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE MONONITRATE3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3.4 mg
INOSITOL NIACINATE (UNII: A99MK953KZ) (INOSITOL NIACINATE - UNII:A99MK953KZ) INOSITOL NIACINATE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN100 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL800 [iU]
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-30 [iU]
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN300 ug
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
ZINC SULFATE MONOHYDRATE (UNII: PTX099XSF1) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 mg
CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorpurpleScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code TriCare;DHA;401
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67112-401-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2012
2NDC:67112-401-9090 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2012
Labeler - Medecor Pharma, LLC (830621046)
Registrant - Medecor Pharma, LLC (830621046)

Revised: 11/2020
Document Id: d983d867-c8e0-4636-bb62-bacfd3cae0e1
Set id: d120a896-04ee-4669-ad37-4fd138617302
Version: 10
Effective Time: 20201105
 
Medecor Pharma, LLC