TRICARE PRENATAL DHA ONE RX

Manufacturer
Medecor Pharma, LLC
Effective date
2020-11-05
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:07:05

Label at a glance#

ProductTRICARE PRENATAL DHA ONE RX MULTIVITAMIN
Active ingredientFISH OIL, DOCONEXENT, ICOSAPENT, THIAMINE MONONITRATE, RIBOFLAVIN, INOSITOL NIACINATE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, FOLIC ACID, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, D-, BIOTIN, FERROUS FUMARATE, ZINC SULFATE MONOHYDRATE, CUPRIC SULFATE ANHYDROUS, POTASSIUM IODIDE, DOCUSATE SODIUM
Label structure12 sections

Boxed 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.

Dosage and administration

One softgel daily or as directed by a physician.

Storage and handling

NOTICE:  Contact with moisture may produce surface discoloration or erosion of the softgel. Store at controlled room temperature of:  20 o -25 o C (68 o -77 o F). Excursions permitted to 15 o -30 o C (59 o -86 o F). KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Marketed by Medecor Pharma LLC, Baton Rouge, LA

Label contents#

Full prescribing information#

Description:

DESCRIPTION SECTION

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:

INACTIVE INGREDIENT SECTION

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:

CONTRAINDICATIONS SECTION

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

WARNING:

BOXED WARNING SECTION

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 SECTION

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B-12 is deficient.

PRECAUTIONS:

PRECAUTIONS SECTION

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:

ADVERSE REACTIONS SECTION

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

One softgel daily or as directed by a physician.

HOW SUPPLIED:

HOW SUPPLIED SECTION

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:

BOXED WARNING SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DHA RX label_67112-402-30DHA RX label_67112-402-30

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67112-402-30EA - Each67112-40254e575bf-0887-40c3-b393-acc15ba9588312020-02-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67112-40267112-402-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
06d7d658-ffda-01e5-e063-6294a90ac63a71aaadea-b55e-45ed-90cc-5b1a162306632023-10-03Boxed warning, Adverse reactionsExact identifier
spl set id: 71aaadea-b55e-45ed-90cc-5b1a16230663

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.