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 
Medecor Pharma, LLC

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.

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MEDECOR PHARMA - TRICARE PRENATAL DHA ONE RX (67112-402) - DELISTED

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

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:  20 o-25 oC (68 o-77 oF).

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

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

Marketed by Medecor Pharma LLC, Baton Rouge, LA

DHA RX label_67112-402-30

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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67112-402
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
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION150 ug
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM25 ug
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Product Characteristics
ColorpurpleScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code DHA402
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67112-402-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/15/201912/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/15/201912/31/2021
Labeler - Medecor Pharma, LLC (830621046)

Revised: 10/2023
 
Medecor Pharma, LLC