Wednesday, September 7, 2016

Tricare Prenatal





Dosage Form: tablet, coated
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 TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)67112-101
Route of AdministrationORALDEA Schedule    












































Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (ASCORBIC ACID)ASCORBIC ACID100 mg
CHOLECALCIFEROL (CHOLECALCIFEROL)CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL ACETATE, DL-).ALPHA.-TOCOPHEROL ACETATE, DL-30 [iU]
THIAMINE HYDROCHLORIDE (THIAMINE)THIAMINE HYDROCHLORIDE1.6 mg
RIBOFLAVIN (RIBOFLAVIN)RIBOFLAVIN1.6 mg
NIACINAMIDE (NIACINAMIDE)NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE)PYRIDOXINE HYDROCHLORIDE3.1 mg
FOLIC ACID (FOLIC ACID)FOLIC ACID1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN)CYANOCOBALAMIN12 ug
CALCIUM CARBONATE (CALCIUM CATION)CALCIUM CARBONATE200 mg
FERROUS FUMARATE (IRON)FERROUS FUMARATE27 mg
ZINC OXIDE (ZINC CATION)ZINC OXIDE10 mg
CUPRIC SULFATE (CUPRIC CATION)CUPRIC SULFATE2 mg










































Inactive Ingredients
Ingredient NameStrength
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
Colorblue (light blue)Score2 pieces
ShapeOVALSize19mm
FlavorImprint CodeMP;101
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
167112-101-00100 TABLET In 1 BOTTLE, PLASTICNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/11/2002


Labeler - Medecor Pharma, LLC (830621046)

Registrant - Medecor Pharma, LLC (830621046)









Establishment
NameAddressID/FEIOperations
Catalent Australia PTY LTD753617638manufacture
Revised: 01/2012Medecor Pharma, LLC



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