FDA.reportPublic FDA data

TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM

Manufacturer
Medecor Pharma, LLC
Effective date
2020-11-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-05-31 20:33:56

Label at a glance#

ProductTRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM
Active ingredientDOCONEXENT, ICOSAPENT, OMEGA-3 FATTY ACIDS, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL SUCCINATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, FERRIC PYROPHOSPHATE, ZINC, SODIUM SELENITE, COPPER GLUCONATE, MANGANESE CITRATE DECAHYDRATE, CHROMIC CHLORIDE CR-51, SODIUM MOLYBDATE
Label structure2 sections

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Chewable Retail BoxChewable Retail Box

Chewable Tablet 1_LBLChewable Tablet 1_LBL

Twist-Off DHA Softgel_LBLTwist-Off DHA Softgel_LBL

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
FERRIC CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
LEVOMEFOLIC ACID Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230428
MANGANESE CATION (2+) Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
OMEGA-3 FATTY ACIDS Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f6766515-27b8-72de-2010-167151236aceProduct name720251021
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
ef9a935e-31b7-402c-a66c-716cdfe4f126Product name920241218
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
115c5bd2-98e1-4a98-8292-90803ca7e851Product name120220127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67112-502-602022-01-28C16284748780-19d75b9d0-f154-f424-e053-dadaa90a57ceTRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM
67112-502-602020-11-17C16284748780-19d75b9d0-f154-f424-e053-dadaa90a57ceTRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM
67112-502-602020-01-31C16284748780-19d75b9d0-f154-f424-e053-dadaa90a57ceTRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67112-201-60TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM1 in 1 BOTTLETABLET, CHEWABLE17 mg13
67112-502-60TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM1 in 1 BOXKIT113
67112-802-60TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM60 in 1 BOTTLECAPSULE, GELATIN COATED17513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67112-201TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM (18 ESSENTIAL VITAMINS AND MINERALS, ULTRA PURE DHA) KIT [MEDECOR PHARMA, LLC]13Unmatched20201117_129283a5-516a-4157-bdd6-2ec41f43eae5.zip
67112-502TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM (18 ESSENTIAL VITAMINS AND MINERALS, ULTRA PURE DHA) KIT [MEDECOR PHARMA, LLC]13Legacy NDC, 3 package rows20201117_129283a5-516a-4157-bdd6-2ec41f43eae5.zip
67112-802TRICARE PRENATAL 2-PART DAILY PRENATAL VITAMIN SYSTEM (18 ESSENTIAL VITAMINS AND MINERALS, ULTRA PURE DHA) KIT [MEDECOR PHARMA, LLC]13Unmatched20201117_129283a5-516a-4157-bdd6-2ec41f43eae5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67112-502-60EA - Each67112-502ca57ffb9-bc4d-4d34-ad4f-9315490c8ca812016-07-19

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 56 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67112-50267112-502-60
67112-80267112-802-60
67112-20167112-201-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCONEXENTZAD9OKH9JCACTIB
ICOSAPENTAAN7QOV9EAACTIB
OMEGA-3 FATTY ACIDS71M78END5SACTIB
GELATIN2G86QN327LIACT
COCHINEALTZ8Z31B35MIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
COCONUT OILQ9L0O73W7LIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
TOCOPHEROLR0ZB2556P8IACT
SUCRALOSE96K6UQ3ZD4IACT
XYLITOLVCQ006KQ1EIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ORANGE OILAKN3KSD11BIACT
ASCORBIC ACIDPQ6CK8PD0RACTIB
CHOLECALCIFEROL1C6V77QF41ACTIB
.ALPHA.-TOCOPHEROL SUCCINATE, D-LU4B53JYVEACTIB
THIAMINE MONONITRATE8K0I04919XACTIR
RIBOFLAVINTLM2976OFRACTIB
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIM
LEVOMEFOLIC ACID8S95DH25XCACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
BIOTIN6SO6U10H04ACTIB
CALCIUM PANTOTHENATE568ET80C3DACTIM
FERRIC PYROPHOSPHATEQK8899250FACTIM
ZINCJ41CSQ7QDSACTIB
SODIUM SELENITEHIW548RQ3WACTIR
COPPER GLUCONATERV823G6G67ACTIM
MANGANESE CITRATE DECAHYDRATE4Z2OA6A13NACTIB
CHROMIC CHLORIDE CR-51U4M5Y13FGMACTIB
SODIUM MOLYBDATE948QAQ08I1ACTIB
MANNITOL3OWL53L36AIACT
CROSPOVIDONE2S7830E561IACT
POLYVINYL ACETATE32K497ZK2UIACT
MAGNESIUM STEARATE70097M6I30IACT
SUCRALOSE96K6UQ3ZD4IACT
POVIDONEFZ989GH94EIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
045e4470-49e8-465f-abbf-c583dd67708c129283a5-516a-4157-bdd6-2ec41f43eae52020-11-13Exact identifier
spl id: 045e4470-49e8-465f-abbf-c583dd67708c
spl set id: 129283a5-516a-4157-bdd6-2ec41f43eae5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.