Tricare prenatal dha one capsule, gelatin coated

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

Indications and usage:

TriCare® Prenatal DHA ONE® Multivitamin/Mineral softgels are indicated to provide multivitamin/mineral/essential fatty acid supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.

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 90 softgels. (NDC 67112-401-90).

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: 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

Ingredients and appearance - Product information

Tricare prenatal dha one capsule, gelatin coated- Multivitamin/mineral

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 67112-401
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Fish oil ( UNII: XGF7L72M0F)( Fish oil - UNII: XGF7L72M0F ) 500 mgin 1
Doconexent ( UNII: ZAD9OKH9JC)( Doconexent - UNII: ZAD9OKH9JC ) 215 mgin 1
Icosapent ( UNII: AAN7QOV9EA)( Icosapent - UNII: AAN7QOV9EA ) 45 mgin 1
Thiamine mononitrate ( UNII: 8K0I04919X)( Thiamine - UNII: X66NSO3N35 ) 3 mgin 1
Riboflavin ( UNII: TLM2976OFR)( Riboflavin - UNII: TLM2976OFR ) 3.4 mgin 1
Inositol niacinate ( UNII: A99MK953KZ)( Inositol niacinate - UNII: A99MK953KZ ) 20 mgin 1
Pyridoxine hydrochloride ( UNII: 68Y4CF58BV)( Pyridoxine - UNII: KV2JZ1BI6Z ) 25 mgin 1
Cyanocobalamin ( UNII: P6YC3EG204)( Cyanocobalamin - UNII: P6YC3EG204 ) 100 ugin 1
Folic acid ( UNII: 935E97BOY8)( Folic acid - UNII: 935E97BOY8 ) 1 mgin 1
Ascorbic acid ( UNII: PQ6CK8PD0R)( Ascorbic acid - UNII: PQ6CK8PD0R ) 60 mgin 1
Cholecalciferol ( UNII: 1C6V77QF41)( Cholecalciferol - UNII: 1C6V77QF41 ) 800 [iU]in 1
Alpha-tocopherol, d- ( UNII: N9PR3490H9)( Alpha-tocopherol, d- - UNII: N9PR3490H9 ) 30 [iU]in 1
Biotin ( UNII: 6SO6U10H04)( Biotin - UNII: 6SO6U10H04 ) 300 ugin 1
Ferrous fumarate ( UNII: R5L488RY0Q)( Iron - UNII: E1UOL152H7 ) 27 mgin 1
Zinc sulfate monohydrate ( UNII: PTX099XSF1)( Zinc cation - UNII: 13S1S8SF37 ) 10 mgin 1
Cupric sulfate anhydrous ( UNII: KUW2Q3U1VV)( Cupric cation - UNII: 8CBV67279L ) 2 mgin 1
Docusate sodium ( UNII: F05Q2T2JA0)( Docusate - UNII: M7P27195AG ) 25 mgin 1

Inactive Ingredients

Ingredient Name Code
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

Score 1 Shape CAPSULE
Imprint Code TriCare;DHA;401 Size 21 mm
Color purple

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA

Labeler - Medecor Pharma, LLC( 830621046)

Establishment

Name ID/FEI Business Operations
Medecor Pharma, LLC 830621046 manufacture()

Principal display panel




TriCare® Prenatal

DHA ONE®

Multivitamin/Mineral

Softgel

ESSENTIAL NUTRITION FOR THE THREE

VITAL STAGES OF PREGNANCY

  • Preconception
  • Pregnancy
  • Postnatal
NDC 67112-401-90

Rx Only