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  5. Label Information: Tricare Prenatal

FDA Label for Tricare Prenatal

View Indications, Usage & Precautions

Table of Contents

    1. DESCRIPTION:
    2. INDICATIONS AND USAGE:
    3. CONTRAINDICATIONS:
    4. WARNING:
    5. GENERAL PRECAUTIONS
    6. PRECAUTIONS:
    7. ADVERSE REACTIONS:
    8. DOSAGE AND ADMINISTRATION:
    9. HOW SUPPLIED:
    10. OTHER INGREDIENTS:
    11. STORAGE AND HANDLING
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tricare Prenatal Product Label

The following document was submitted to the FDA by the labeler of this product Medecor Pharma, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


General Precautions



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.


Storage And Handling



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


Package Label.Principal Display Panel



label_30 - label 30

label_30 - label 30


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