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
Medecor Pharma, LLC
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.
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.
| 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 |
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||
| Labeler - Medecor Pharma, LLC (830621046) |
| Registrant - Medecor Pharma, LLC (830621046) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Catalent Australia PTY LTD | 753617638 | manufacture | |