TRICARE PRENATAL COMPLEAT- essential fatty acids, multivitamins, minerals kit

TRICARE PRENATAL COMPLEAT by

Drug Labeling and Warnings

TRICARE PRENATAL COMPLEAT by is a Prescription medication manufactured, distributed, or labeled by Medecor Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRICARE PRENATAL COMPLEAT 
essential fatty acids, multivitamins, minerals kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 67112-501

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67112-501-31	1 in 1 BOX	03/21/2013

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	1
Part 2	1 BOTTLE	1

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	135 mg
GONDOIC ACID (UNII: UDX6WPL94T) (GONDOIC ACID - UNII:UDX6WPL94T)	GONDOIC ACID	33.8 mg
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)	OMEGA-3 FATTY ACIDS	71.2 mg

Inactive Ingredients
Ingredient Name	Strength
FISH OIL (UNII: XGF7L72M0F)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)	3.2 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Product Characteristics
Color	purple	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	TriCare;DHA;401
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67112-601-30	1 in 1 BOTTLE; Type 0: Not a Combination Product

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	100 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	30 [iU]
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE ION	1.6 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1.6 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	3.1 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 mg
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	27 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 mg
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L)	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	Marketing Start Date	Marketing End Date
1	NDC: 67112-701-30	1 in 1 BOTTLE; Type 0: Not a Combination Product

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)