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.
TRICARE PRENATAL DHA ONE
- Manufacturer
- Medecor Pharma, LLC
- Effective date
- 2020-11-05
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 10
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:07:09
Label at a glance#
ProductTRICARE PRENATAL DHA ONE
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, DOCUSATE SODIUM
Label structure12 sections
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:
Each purple softgel contains:
| Essential Fatty Acids | |
| Fish Oil Concentrate 10/50 TG | 500 mg |
| DHA | 215 mg |
| EPA | 45 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 Acid | 1 mg |
| Vitamin C (Ascorbic Acid) | 60 mg |
| Vitamin D3 (Cholecalciferol) | 800 IU |
| Vitamin E (d-alpha-Tocopherol) | 30 IU |
| Biotin | 300 mcg |
| Minerals | |
| 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
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.
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:
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.
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67112-401-30 | 2020-11-17 | C162847 | 48780-1 | 9d75b9d0-0985-f424-e053-dadaa90a57ce | TRICARE PRENATAL DHA ONE |
| 67112-401-90 | 2020-11-17 | C162847 | 48780-1 | 9d75b9d0-0985-f424-e053-dadaa90a57ce | TRICARE PRENATAL DHA ONE |
| 67112-401-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-0985-f424-e053-dadaa90a57ce | TRICARE PRENATAL DHA ONE |
| 67112-401-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-0985-f424-e053-dadaa90a57ce | TRICARE PRENATAL DHA ONE |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67112-401-30 | EA - Each | 67112-401 | a8c93fb9-0c7b-404b-8b58-92ee931a4416 | 1 | 2012-07-24 |
| 67112-401-90 | EA - Each | 67112-401 | aa669f17-6947-4215-afcc-ed4b437d07a6 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ALPHA-TOCOPHEROL, D- | ACTIVE INGREDIENT | N9PR3490H9 | 1 | |
| ASCORBIC ACID | ACTIVE INGREDIENT | PQ6CK8PD0R | 1 | |
| BIOTIN | ACTIVE INGREDIENT | 6SO6U10H04 | 1 | |
| CHOLECALCIFEROL | ACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| CUPRIC SULFATE ANHYDROUS | ACTIVE INGREDIENT | KUW2Q3U1VV | 1 | |
| CYANOCOBALAMIN | ACTIVE INGREDIENT | P6YC3EG204 | 1 | |
| DOCONEXENT | ACTIVE INGREDIENT | ZAD9OKH9JC | 1 | |
| DOCUSATE SODIUM | ACTIVE INGREDIENT | F05Q2T2JA0 | 1 | |
| FERROUS FUMARATE | ACTIVE INGREDIENT | R5L488RY0Q | 1 | |
| FISH OIL | ACTIVE INGREDIENT | XGF7L72M0F | 1 | |
| FOLIC ACID | ACTIVE INGREDIENT | 935E97BOY8 | 1 | |
| ICOSAPENT | ACTIVE INGREDIENT | AAN7QOV9EA | 1 | |
| INOSITOL NIACINATE | ACTIVE INGREDIENT | A99MK953KZ | 1 | |
| PYRIDOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 68Y4CF58BV | 1 | |
| RIBOFLAVIN | ACTIVE INGREDIENT | TLM2976OFR | 1 | |
| THIAMINE MONONITRATE | ACTIVE INGREDIENT | 8K0I04919X | 1 | |
| ZINC SULFATE MONOHYDRATE | ACTIVE INGREDIENT | PTX099XSF1 | 1 | |
| ALPHA-TOCOPHEROL, D- | ACTIVE MOIETY | N9PR3490H9 | 1 | |
| ASCORBIC ACID | ACTIVE MOIETY | PQ6CK8PD0R | 1 | |
| BIOTIN | ACTIVE MOIETY | 6SO6U10H04 | 1 | |
| CHOLECALCIFEROL | ACTIVE MOIETY | 1C6V77QF41 | 1 | |
| CUPRIC CATION | ACTIVE MOIETY | 8CBV67279L | 1 | |
| CYANOCOBALAMIN | ACTIVE MOIETY | P6YC3EG204 | 1 | |
| DOCONEXENT | ACTIVE MOIETY | ZAD9OKH9JC | 1 | |
| DOCUSATE | ACTIVE MOIETY | M7P27195AG | 1 | |
| FISH OIL | ACTIVE MOIETY | XGF7L72M0F | 1 | |
| FOLIC ACID | ACTIVE MOIETY | 935E97BOY8 | 1 | |
| ICOSAPENT | ACTIVE MOIETY | AAN7QOV9EA | 1 | |
| INOSITOL NIACINATE | ACTIVE MOIETY | A99MK953KZ | 1 | |
| IRON | ACTIVE MOIETY | E1UOL152H7 | 1 | |
| PYRIDOXINE | ACTIVE MOIETY | KV2JZ1BI6Z | 1 | |
| RIBOFLAVIN | ACTIVE MOIETY | TLM2976OFR | 1 | |
| THIAMINE | ACTIVE MOIETY | X66NSO3N35 | 1 | |
| ZINC CATION | ACTIVE MOIETY | 13S1S8SF37 | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| COCHINEAL | INACTIVE INGREDIENT | TZ8Z31B35M | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| LEMON OIL | INACTIVE INGREDIENT | I9GRO824LL | 1 | |
| LIME OIL | INACTIVE INGREDIENT | UZH29XGA8G | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | 1 |
Products#
Every source-derived product name is available through these pages.
- 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
- FISH OIL
- DOCONEXENT
- ICOSAPENT
- THIAMINE MONONITRATE
- THIAMINE ION
- RIBOFLAVIN
- INOSITOL NIACINATE
- PYRIDOXINE HYDROCHLORIDE
- PYRIDOXINE
- CYANOCOBALAMIN
- FOLIC ACID
- ASCORBIC ACID
- CHOLECALCIFEROL
- .ALPHA.-TOCOPHEROL, D-
- BIOTIN
- FERROUS FUMARATE
- FERROUS CATION
- ZINC SULFATE MONOHYDRATE
- ZINC CATION
- GELATIN
- GLYCERIN
- WATER
- YELLOW WAX
- LECITHIN, SOYBEAN
- SILICON DIOXIDE
- ALCOHOL
- LIME OIL
- COCHINEAL
- LEMON OIL
- TITANIUM DIOXIDE
- POLYSORBATE 80
- CUPRIC SULFATE ANHYDROUS
- CUPRIC CATION
- DOCUSATE SODIUM
- DOCUSATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67112-401 | 67112-401-30, 67112-401-90 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET / ORAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION/ DROPS / AURICULAR (OTIC) | 13 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRASYNOVIAL | 0.2 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | GRANULE, FOR SUSPENSION / ORAL | 240 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / INTRACAVITARY | 0.05 ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| LEMON OIL | LEMON OIL, COLD PRESSED | I9GRO824LL | PASTE, DENTIFRICE / DENTAL | 0.7 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, LIQUID FILLED / ORAL | 24 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / INTRAVENOUS | 900 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| YELLOW WAX | YELLOW WAX | 2ZA36H0S2V | TABLET, SUGAR COATED / ORAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / RECTAL | 315 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | PASTE / ORAL | 28 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 2 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, COATED / ORAL | 18 mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET / PERIODONTAL | 3.44 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET / SUBLINGUAL | 0.08 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / NASAL | 50 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / OPHTHALMIC | 8 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / RECTAL | 72.15 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRAVENOUS | 4680 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 69 mg | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 1 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| GELATIN | GELATIN | 2G86QN327L | DROPS / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 06d7a8e9-1388-0fef-e063-6294a90a4366 | d120a896-04ee-4669-ad37-4fd138617302 | 2023-10-03 | Boxed warning, Adverse reactions | d120a896-04ee-4669-ad37-4fd138617302 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.