TRICARE Operations Manual 6010.59-M, April 1, 2015 TRICARE ...
TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM
Transcript of 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
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
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
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
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