TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM- 18 essential vitamins and minerals, ultra pure dha kit

TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM by

Drug Labeling and Warnings

TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM by is a Prescription medication manufactured, distributed, or labeled by Medecor Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

INDICATIONS AND USAGE: TriCare Prenatal™ Chewable
Tablets with Twist-off DHA Softgels are indicated to provide
vitamin and mineral 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.
NOTICE: Contact with moisture may produce surface
discoloration or erosion of the tablets and twist-off softgels.
ADVERSE REACTIONS: Allergic sensitization has been
reported following both oral and parenteral administration
of folic acid.
DOSAGE: Two (2) chewable tablets and two (2) twist-off
softgels daily or as directed by a physician.
ADMINISTRATION: Chew tablets before swallowing. Twist
small end off from softgel and squeeze contents directly into
mouth or into juice to drink. Daily dosage should be taken
with food.
HOW SUPPLIED: Child-resistant, blister pack of two (2) white
tablets and two (2) purple twist-off softgels.
Each tablet is embossed MP 201.
Each Twist-off softgel is marked MP 802.
(NDC: 67112-502-60)
Store at controlled room temperature, 15º-30ºC (59º-86ºF).
TO REPORT a serious adverse event or obtain product
information, call 877-803-8235.
KEEP THIS AND ALL DRUGS OUT OF THE REACH
OF CHILDREN.
Marketed by: Medecor Pharma, LLC, Baton Rouge, LA
Patent Pending

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM 
18 essential vitamins and minerals, ultra pure dha kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 67112-502

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67112-502-60	1 in 1 BOX	05/10/2016

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 TWIST-OFF DHA SOFT  QUICK DISSOLVE
dha, epa, other omega-3s capsule, gelatin coated

Product Information
Item Code (Source)	NHRIC:67112-802
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	150
ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA)	ICOSAPENT	37.5
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)	OMEGA-3 FATTY ACIDS	75

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
COCHINEAL (UNII: TZ8Z31B35M)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
COCONUT OIL (UNII: Q9L0O73W7L)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
TOCOPHEROL (UNII: R0ZB2556P8)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ORANGE OIL (UNII: AKN3KSD11B)

Product Characteristics
Color	purple	Score	no score
Shape	CAPSULE	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:67112-802-60	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
dietary supplement		05/10/2016

Part 2 of 2

TRICARE PRENATAL  QUICK DISSOLVE
18 essential vitamins and minerals tablet, chewable

Product Information
Item Code (Source)	NHRIC:67112-201
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	30 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL SUCCINATE, D-	15 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.25 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	.85 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	10 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	2.5 mg
LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	.125 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	.150 mg
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737)	PANTOTHENIC ACID	5 mg
FERRIC PYROPHOSPHATE (UNII: QK8899250F) (FERRIC CATION - UNII:91O4LML611)	FERRIC CATION	4.5 mg
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	7 mg
SODIUM SELENITE (UNII: HIW548RQ3W) (SELENITE ION - UNII:KXO0259XJ1)	SODIUM SELENITE	.0325 mg
COPPER GLUCONATE (UNII: RV823G6G67) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	1 mg
MANGANESE CITRATE DECAHYDRATE (UNII: 4Z2OA6A13N) (MANGANESE CATION (2+) - UNII:H6EP7W5457)	MANGANESE CITRATE DECAHYDRATE	1 mg
CHROMIC CHLORIDE CR-51 (UNII: U4M5Y13FGM) (CHROMIUM CR-51 - UNII:9QAU17N705)	CHROMIC CHLORIDE CR-51	.060 mg
SODIUM MOLYBDATE (UNII: 948QAQ08I1) (MOLYBDATE ION - UNII:O0L10E6352)	SODIUM MOLYBDATE	.0375 mg

Inactive Ingredients
Ingredient Name	Strength
MANNITOL (UNII: 3OWL53L36A)
CROSPOVIDONE (UNII: 68401960MK)
POLYVINYL ACETATE (UNII: 32K497ZK2U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:67112-201-60	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
dietary supplement		03/21/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/10/2016

Labeler - Medecor Pharma, LLC (830621046)