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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC), ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA), OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)
Available from:
Medecor Pharma, LLC
INN (International Name):
DOCONEXENT
Composition:
DOCONEXENT 150
Prescription type:
PRESCRIPTION DRUG
Authorization status:
unapproved drug other
Authorization number:
67112-201-60, 67112-502-60, 67112-802-60

TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM- 18 essential

vitamins and minerals, ultra pure dha

Medecor Pharma, LLC

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.

----------

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

TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM

18 essential vitamins and minerals, ultra pure dha kit

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 7112-50 2

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 7112-50 2-6 0

1 in 1 BOX

0 5/10 /20 16

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 BOTTLE

Pa rt 2

1 BOTTLE

Part 1 of 2

TRICARE PRENATAL TWIST-OFF DHA SOFT QUICK DISSOLVE

dha, epa, other omega-3s capsule, gelatin coated

Product Information

Ite m Code (Source )

NHRIC:6 7112-8 0 2

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DO CO NEXENT (UNII: ZAD9 OKH9 JC) (DOCONEXENT - UNII:ZAD9 OKH9 JC)

DOCONEXENT

ICO SAPENT (UNII: AAN7QOV9 EA) (ICOSAPENT - UNII:AAN7QOV9 EA)

ICOSAPENT

37.5

O MEGA-3 FATTY ACIDS (UNII: 71M78 END5S) (OMEGA-3 FATTY ACIDS -

UNII:71M78 END5S)

OMEGA-3 FATTY ACIDS 75

Inactive Ingredients

Ingredient Name

Stre ng th

GELATIN (UNII: 2G8 6 QN327L)

CO CHINEAL (UNII: TZ8 Z31B35M)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

GLYCERIN (UNII: PDC6 A3C0 OX)

WATER (UNII: 0 59 QF0 KO0 R)

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

XYLITO L (UNII: VCQ0 0 6 KQ1E)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

O RANGE O IL (UNII: AKN3KSD11B)

Product Characteristics

Color

purple

S core

no sco re

S hap e

CAPSULE

S iz e

9 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NHRIC:6 7112-8 0 2-6 0

1 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

dietary supplement

0 5/10 /20 16

Part 2 of 2

TRICARE PRENATAL QUICK DISSOLVE

18 essential vitamins and minerals tablet, chewable

Product Information

Ite m Code (Source )

NHRIC:6 7112-20 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R) (ASCORBIC ACID - UNII:PQ6 CK8 PD0 R)

ASCORBIC ACID

30 mg

CHO LECALCIFERO L (UNII: 1C6 V77QF41) (CHOLECALCIFEROL - UNII:1C6 V77QF41)

CHOLECALCIFEROL

40 0 [iU]

.ALPHA.-TO CO PHERO L SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-

TOCOPHEROL, D- - UNII:N9 PR349 0 H9 )

.ALPHA.-TOCOPHEROL

SUCCINATE, D-

15 [iU]

THIAMINE MO NO NITRATE (UNII: 8 K0 I0 49 19 X) (THIAMINE ION - UNII:4ABT0 J9 45J)

THIAMINE

1.25 mg

RIBO FLAVIN (UNII: TLM29 76 OFR) (RIBOFLAVIN - UNII:TLM29 76 OFR)

RIBOFLAVIN

.8 5 mg

NIACINAMIDE (UNII: 25X51I8 RD4) (NIACINAMIDE - UNII:25X51I8 RD4)

NIACINAMIDE

10 mg

PYRIDO XINE HYDRO CHLO RIDE (UNII: 6 8 Y4CF58 BV) (PYRIDOXINE -

UNII:KV2JZ1BI6 Z)

PYRIDOXINE

2.5 mg

LEVO MEFO LIC ACID (UNII: 8 S9 5DH25XC) (LEVOMEFOLIC ACID -

UNII:8 S9 5DH25XC)

LEVOMEFOLIC ACID

1 mg

CYANO CO BALAMIN (UNII: P6 YC3EG20 4) (CYANOCOBALAMIN - UNII:P6 YC3EG20 4)

CYANOCOBALAMIN

.125 mg

BIO TIN (UNII: 6 SO6 U10 H0 4) (BIOTIN - UNII:6 SO6 U10 H0 4)

BIOTIN

.150 mg

CALCIUM PANTO THENATE (UNII: 56 8 ET8 0 C3D) (PANTOTHENIC ACID -

UNII:19 F5HK2737)

PANTOTHENIC ACID

5 mg

FERRIC PYRO PHO SPHATE (UNII: QK8 8 9 9 250 F) (FERRIC CATION -

UNII:9 1O4LML6 11)

FERRIC CATION

4.5 mg

ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)

ZINC

7 mg

SO DIUM SELENITE (UNII: HIW548 RQ3W) (SELENITE ION - UNII:KXO0 259 XJ1)

SODIUM SELENITE

.0 325 mg

CO PPER GLUCO NATE (UNII: RV8 23G6 G6 7) (CUPRIC CATION - UNII:8 CBV6 7279 L)

CUPRIC CATION

1 mg

MANGANESE CITRATE DECAHYDRATE (UNII: 4Z2OA6 A13N) (MANGANESE CATION

(2+) - UNII:H6 EP7W5457)

MANGANESE CITRATE

DECAHYDRATE

1 mg

CHRO MIC CHLO RIDE CR-51 (UNII: U4M5Y13FGM) (CHROMIUM CR-51 -

UNII:9 QAU17N70 5)

CHROMIC CHLORIDE CR-51

.0 6 0 mg

SO DIUM MO LYBDATE (UNII: 9 48 QAQ0 8 I1) (MOLYBDATE ION - UNII:O0 L10 E6 352)

SODIUM MOLYBDATE

.0 375 mg

Inactive Ingredients

Medecor Pharma, LLC

Inactive Ingredients

Ingredient Name

Stre ng th

MANNITO L (UNII: 3OWL53L36 A)

CRO SPO VIDO NE (UNII: 6 8 40 19 6 0 MK)

PO LYVINYL ACETATE (UNII: 32K49 7ZK2U)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

Product Characteristics

Color

white

S core

no sco re

S hap e

OVAL

S iz e

9 mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NHRIC:6 7112-20 1-6 0

1 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

dietary supplement

0 3/21/20 13

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved drug o ther

0 5/10 /20 16

Labeler -

Medecor Pharma, LLC (830621046)

Revised: 5/2016

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