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Tricare Prenatal Compleat

Generic Name: essential fatty acids, multivitamins, mineral
Dosage Form: kit

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.

DESCRIPTION: Each light blue film coated tablet contains:
Vitamins

  • Vitamin C (Ascorbic Acid) 100 mg 167%
  • Vitamin D-3 (Cholecalciferol) 400 I.U. 100%
  • Vitamin E (dl-Alpha Tocopheryl Acetate) 30 I.U. 100%
  • Vitamin B-1 (Thiamine HCL) 1.6 mg. 94%
  • Vitamin B-2 (Riboflavin) 1.6 mg. 80%
  • Niacin (Niacinamide) 20 mg. 100%
  • Vitamin B-6 (Pyridoxine HCL) 3.1 mg. 124%
  • Folic Acid 1 mg. 125%
  • Vitamin B-12 (Cyanocobalamin) 12 mcg. 150%

Minerals

  • Calcium (Calcium Carbonate) 200 mg. 15%
  • Iron (Ferrous Fumarate) 27 mg. 150%
  • Zinc (Zinc Oxide) 10 mg. 67%
  • Copper (Cupric Sulfate) 2 mg. 100%

DESCRIPTION: Each pink chewable softgel contains:
Essential Fatty Acids
Fish Oil Concentrate

  • DHA (Docosahexaenoic acid) 135.0 mg
  • EPA (Eicosapentaenoic acid) 33.80 mg
  • Other Omega-3’s 71.20 mg

DESCRIPTION: Each light blue film coated tablet contains:

OTHER INGREDIENTS: Aerosil 200V, carnauba wax, FD&C blue #1 Lake, FD&C blue #2 Lake, FD&C red#40 Lake, Kollidon® 30,
magnesium stearate, microcrystalline cellulose, Opadry, Polyplasdone® XL, sodium starch glycolate.

DESCRIPTION: Each pink chewable softgel contains:

OTHER INGREDIENTS: Highly refined and concentrated Omega-3 Fish Oil (Tuna) capsule (gelatin, potato starch, cochineal C175470,
iron oxide black C177499, titanium dioxide), coconut oil-fractionated, lecithin, natural vitamin E (d-aplha -Tocopherol
3.22 mg as vitamin E preparation USP), TS- 12550/ ARTG 13165, sucralose, xylitol (this material contains galactose, glucose,
sucrose, invert sugar, mannitol and sorbitol) citric acid-anhydrous, orange oil, forest fruits flavour 174289941/ARTG-11546.

Tricare Prenatal Compleat 
essential fatty acids, multivitamins, minerals kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67112-501
Packaging
# Item Code Package Description
1 NDC:67112-501-31 1 KIT in 1 BOX
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE
Part 2 1 BOTTLE
Part 1 of 2
Tricare Prenatal Compleat  DHA ONE
essential fatty acids capsule, gelatin coated
Product Information
Item Code (Source) NDC:67112-601    
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 135 mg
GONDOIC ACID (GONDOIC ACID) GONDOIC ACID 33.8 mg
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) OMEGA-3 FATTY ACIDS 71.2 mg
Inactive Ingredients
Ingredient Name Strength
FISH OIL  
.ALPHA.-TOCOPHEROL, DL- 3.2 mg
TITANIUM DIOXIDE  
FERROSOFERRIC OXIDE  
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:67112-601-30 1 CAPSULE, GELATIN COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/21/2013
Part 2 of 2
Tricare Prenatal Compleat  MULTIVITAMIN MINERAL
multivitamins, minerals tablet, coated
Product Information
Item Code (Source) NDC:67112-701    
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 30 [iU]
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE ION 1.6 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.6 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 3.1 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 200 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 27 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 10 mg
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 2 mg
Product Characteristics
Color blue Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code MP;101
Contains         
Packaging
# Item Code Package Description
1 NDC:67112-701-30 1 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/21/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/21/2013
Labeler - Medecor Pharma, LLC (830621046)
Revised: 07/2016
 
Medecor Pharma, LLC



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