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Tricare Prenatal

Generic Name: multivitamin / minerals
Dosage Form: kit

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.

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 Acid 1 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:

Tricare 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, 15o-30oC (59o-86oF)

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

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 Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:67112-101
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 30 [iU]
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 1.6 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.6 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 3.1 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 200 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 27 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 10 mg
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 2 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE  
CARNAUBA WAX  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
CROSPOVIDONE  
Product Characteristics
Color blue (light blue) Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code MP;101
Contains         
Packaging
# Item Code Package Description
1 NDC:67112-101-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC
2 NDC:67112-101-00 100 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2012
Labeler - Medecor Pharma, LLC (830621046)
Registrant - Medecor Pharma, LLC (830621046)
Revised: 07/2016
 
Medecor Pharma, LLC



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