Tricare Prenatal DHA ONE

Generic Name: prenatal multi-vitamin / mineral
Dosage Form: capsule, gelatin coated

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.

TriCare Prenatal™ DHA ONE® Softgel

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.

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.

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





TriCare Prenatal™

DHA ONE®

Multivitamin/Mineral

Softgel

ESSENTIAL NUTRITION FOR THE THREE

VITAL STAGES OF PREGNANCY

  • Preconception
  • Pregnancy
  • Postnatal
NDC 67112-401-30

Rx Only
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 capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67112-401
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FISH OIL (FISH OIL) FISH OIL 500 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT 215 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 45 mg
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
INOSITOL NIACINATE (INOSITOL NIACINATE) INOSITOL NIACINATE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 100 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 800 [iU]
ALPHA-TOCOPHEROL, D- (ALPHA-TOCOPHEROL, D-) ALPHA-TOCOPHEROL, D- 30 [iU]
BIOTIN (BIOTIN) BIOTIN 300 ug
FERROUS FUMARATE (IRON) FERROUS FUMARATE 27 mg
ZINC SULFATE MONOHYDRATE (ZINC CATION) ZINC SULFATE MONOHYDRATE 10 mg
CUPRIC SULFATE ANHYDROUS (CUPRIC CATION) CUPRIC SULFATE ANHYDROUS 2 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 25 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
WATER  
YELLOW WAX  
LECITHIN, SOYBEAN  
SILICON DIOXIDE  
ALCOHOL  
LIME OIL  
COCHINEAL  
LEMON OIL  
TITANIUM DIOXIDE  
POLYSORBATE 80  
Product Characteristics
Color purple Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code TriCare;DHA;401
Contains         
Packaging
# Item Code Package Description
1 NDC:67112-401-30 30 CAPSULE, GELATIN COATED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2012
Labeler - Medecor Pharma, LLC (830621046)
Registrant - Medecor Pharma, LLC (830621046)
Establishment
Name Address ID/FEI Operations
Catalent Australia PTY LTD 753617638 manufacture
Revised: 01/2012
 
Medecor Pharma, LLC



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