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

TRICARE PRENATAL DHA ONE RX by

Drug Labeling and Warnings

TRICARE PRENATAL DHA ONE RX 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
• 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.

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® 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).

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 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	Item Code (Source)	NDC: 67112-402
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
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	150 ug
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	25 ug

Inactive Ingredients
Ingredient Name	Strength
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
Color	purple	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	DHA402
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67112-402-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/15/2019

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)