TRICARE PRENATAL description, usages, side effects, indications, overdosage, supplying and lots more!

TRICARE PRENATAL

Medecor Pharma, LLC
Medecor Pharma, LLC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
TRICARE PRENATAL

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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:


PRINCIPAL DISPLAY PANEL:















  • Preconception
  • Pregnancy
  • Postnatal

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 100 mg
CHOLECALCIFEROL CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- 30 [iU]
THIAMINE HYDROCHLORIDE THIAMINE 1.6 mg
RIBOFLAVIN RIBOFLAVIN 1.6 mg
NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 3.1 mg
FOLIC ACID FOLIC ACID 1 mg
Cyanocobalamin CYANOCOBALAMIN 12 ug
CALCIUM CARBONATE 200 mg
FERROUS FUMARATE FERROUS CATION 27 mg
Zinc Oxide Zinc oxide 10 mg
CUPRIC SULFATE CUPRIC CATION 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 Size Imprint Code Shape
blue (light blue) 19 mm MP;101 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67112-101-00 100 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2002-11-11


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