TRICARE PRENATAL- ascorbic acid, cholecalciferol, dl-.alpha.-tocopherol acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric sulfate tablet, coated 
Medecor Pharma, LLC
Reference Label Set Id: 80b11abb-0eb2-4eb4-9067-7ddc053d1b50

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.

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MEDECOR PHARMA - TRICARE PRENATAL (67112-101)

DESCRIPTION:

Each light blue film coated tablet contains:

Vitamin C (Ascorbic Acid)100 mg
Vitamin D-3 (Cholecalciferol)400 IU
Vitamin E (dl-Alpha Tocopheryl Acetate)30 IU
Vitamin B-1 (Thiamine HCl)1.6 mg
Vitamin B-2 (Riboflavin)1.6 mg
Niacin (Niacinamide)20 mg
Vitamin B-6 (Pyridoxine HCl)3.1 mg
Folic Acid1 mg
Vitamin B-12 (Cyanocobalamin)12 mcg
Calcium (Calcium Carbonate)200 mg
Iron (Ferrous Fumarate)27 mg
Zinc (Zinc Oxide)10 mg
Copper (Cupric Sulfate)2 mg

INDICATIONS AND USAGE:

TriCare Prenatal™ tablets 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.

WARNING:

Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6.  Keep this product out of reach of children.  In case of accidental overdose, call a doctor or poison control center right away.

Folic acid alone is improper therapy in the treatment of prenicious anemia and other megaloblastic anemias where vitamin B-12 is deficient.

PRECAUTIONS:

Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

ADVERSE REACTIONS:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION:

One tablet daily or as directed by a physician.

HOW SUPPLIED:

TriCar e Prenatal™ Multivitamin/Mineral Tablets for oral administration are supplied as light blue, film coated tablets, debossed MP 101 with a partial bisect through the tablets on one side.  In a child resistant plastic bottle of 30 tablets (NDC 67112-101-30).

OTHER INGREDIENTS:

Aerosil 200 V, carnauba wax, FD&C blue #1 Lake, FD&C blue #2 Lake, FD&C red #40 Lake, Kollidon® 30, magnesium stearate, microcrystalline cellulose, Opadry, Polyplasdone® XL, sodium starch glycolate.

Store at controlled room temperature, 15 o-30 oC (59 o-86 oF)

NOTICE:  Contact with moisture may produce surface discoloration or erosion of the tablet.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Marketed by Medecor Pharma LLC, Baton Rouge, LA  70802

label_30

label_100

TRICARE PRENATAL 
ascorbic acid, cholecalciferol, dl-.alpha.-tocopherol acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous fumarate, zinc oxide, cupric sulfate tablet, coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67112-101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 [iU]
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE1.6 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.6 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE3.1 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 mg
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CROSPOVIDONE (UNII: 2S7830E561)  
Product Characteristics
Colorblue (light blue) Score2 pieces
ShapeOVALSize19mm
FlavorImprint Code MP;101
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67112-101-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2012
2NDC:67112-101-00100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2012
Labeler - Medecor Pharma, LLC (830621046)

Revised: 1/2022
 
Medecor Pharma, LLC