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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. ---------- TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM 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

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Page 1: TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM

TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM- 18 essentialvitamins and minerals , ultra pure dha Medecor Pharma, LLCDisclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not beenapproved by FDA. For further information about unapproved drugs, click here.

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TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEMINDICATIONS AND USAGE: TriCare Prenatal™ ChewableTablets with Twist-off DHA Softgels are indicated to providevitamin and mineral supplementation throughoutpregnancy and during the postnatal period for both thelactating and non-lactating mother. It is also useful forimproving nutritional status prior to conception.CONTRAINDICATIONS: This product is contraindicated inpatients with a known hypersensitivity to any of theingredients.NOTICE: Contact with moisture may produce surfacediscoloration or erosion of the tablets and twist-off softgels.ADVERSE REACTIONS: Allergic sensitization has beenreported following both oral and parenteral administrationof folic acid.DOSAGE: Two (2) chewable tablets and two (2) twist-offsoftgels daily or as directed by a physician.ADMINISTRATION: Chew tablets before swallowing. Twistsmall end off from softgel and squeeze contents directly intomouth or into juice to drink. Daily dosage should be takenwith food.HOW SUPPLIED: Child-resistant, blister pack of two (2) whitetablets 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 productinformation, call 877-803-8235.KEEP THIS AND ALL DRUGS OUT OF THE REACHOF CHILDREN.Marketed by: Medecor Pharma, LLC, Baton Rouge, LAPatent Pending

Page 2: TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM
Page 3: TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM
Page 4: TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM

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

Product InformationProduct T ype HUMAN PRESCRIPTION DRUG Ite m Code (Source ) NDC:6 7112-50 2

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:6 7112-50 2-6 0 1 in 1 BOX 0 5/10 /20 16

Quantity of Parts

Page 5: TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM

Part # Package Quantity Total Product QuantityPa rt 1 0 BOTTLE 1

Pa rt 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 InformationIte m Code (Source ) NHRIC:6 7112-8 0 2

Route of Adminis tration ORAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

DO CO NEXENT (UNII: ZAD9 OKH9 JC) (DOCONEXENT - UNII:ZAD9 OKH9 JC) DOCONEXENT 150

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 IngredientsIngredient Name Strength

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 CharacteristicsColor purple Score no sco re

Shape CAPSULE Siz e 9 mm

Flavor Imprint Code

Contains

Page 6: TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NHRIC:6 7112-8 0 2-6 0 6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

die tary supplement 0 5/10 /20 16

Part 2 of 2

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

Product InformationIte m Code (Source ) NHRIC:6 7112-20 1

Route of Adminis tration ORAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

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.-TOCOPHEROLSUCCINATE, 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 CITRATEDECAHYDRATE 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

Page 7: TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM

Medecor Pharma, LLC

Inactive IngredientsIngredient Name Strength

MANNITO L (UNII: 3OWL53L36 A)

CRO SPO VIDO NE (UNII: 2S78 30 E56 1)

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 CharacteristicsColor white Score no sco re

Shape OVAL Siz e 9 mm

Flavor Imprint Code

Contains

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NHRIC:6 7112-20 1-6 0 1 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

die tary supplement 0 3/21/20 13

Marketing InformationMarke 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: 11/2020