Tricare Prenatal

Generic Name: multivitamin / minerals
Dosage Form: tablet, coated

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

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 100 tablets (NDC 67112-101-00).

OTHER INGREDIENTS:

acacia, croscarmellose sodium, dicalcium phosphate, FD&C blue #1 Lake, FD&C blue #2 Lake, FD&C red #40 Lake, gelatin, hypromellose, magnesium silicate, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyvinylpyrrolidone, silica, sodium lauryl sulfate, soy polysaccharide, stearic acid, titanium dioxide, and triacetin.

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

PRINCIPAL DISPLAY PANEL:




NDC 67112-101-00

TriCare

PRENATAL

Multivitamin/Mineral

Film Coated Tablet

Complete Nutritional Needs of Women

100 TABLETS

  • Preconception
  • Pregnancy
  • Postnatal
Rx Only
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 ACETATE, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 30 [iU]
THIAMINE HYDROCHLORIDE (THIAMINE) 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 (IRON) FERROUS FUMARATE 27 mg
ZINC OXIDE (ZINC CATION) ZINC OXIDE 10 mg
CUPRIC SULFATE (CUPRIC CATION) CUPRIC SULFATE 2 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA  
CROSCARMELLOSE SODIUM  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
FD&C RED NO. 40  
GELATIN  
HYPROMELLOSES  
MAGNESIUM SILICATE  
MAGNESIUM STEARATE  
MALTODEXTRIN  
CELLULOSE, MICROCRYSTALLINE  
MINERAL OIL  
POVIDONE K30  
SILICON DIOXIDE  
SODIUM LAURYL SULFATE  
STEARIC ACID  
TITANIUM DIOXIDE  
TRIACETIN  
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:67112-101-00 100 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/11/2002
Labeler - Medecor Pharma, LLC (830621046)
Registrant - Medecor Pharma, LLC (830621046)
Establishment
Name Address ID/FEI Operations
Catalent Australia PTY LTD 753617638 manufacture
Revised: 01/2012
 
Medecor Pharma, LLC



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