INDICATIONS & USAGE SECTION.
INDICATIONS AND USAGE:. TriCare(R) Prenatal DHA ONE(R) Multivitamin/Mineral softgels are indicated to provide multivitamin/mineral/essential fatty acid 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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL. TriCare(R) PrenatalDHA ONE(R)Multivitamin/MineralSoftgelESSENTIAL NUTRITION FOR THE THREEVITAL STAGES OF PREGNANCYPreconceptionPregnancyPostnatalNDC 67112-401-90Rx Only. Preconception. Pregnancy. Postnatal. TriCare Prenatal DHA ONE Label.
PRECAUTIONS:. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
STORAGE AND HANDLING SECTION.
NOTICE: Contact with moisture may produce surface discoloration or erosion of the softgel.Store at controlled room temperature of: 20o-25oC (68o-77oF).Excursions permitted to 15o-30oC (59o-86oF).KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.Marketed by Medecor Pharma LLC, Baton Rouge, LA.
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS:. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
BOXED WARNING SECTION.
WARNING:. Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call doctor or poison control center immediately.
CONTRAINDICATIONS:. This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
Description:. Each purple softgel contains:Essential Fatty AcidsFish Oil Concentrate 10/50 TG 500 mg DHA 215 mg EPA 45 mg VitaminsVitamin B-1 (Thiamine Nitrate) mg Vitamin B-2 (Riboflavin) 3.4 mg Vitamin B-3 (Inositol Nicotinate) 20 mg Vitamin B-6 (Pyridoxine Hydrochloride) 25 mg Vitamin B-12 (Cyanocobalamin) 100 mcg Folic Acid mg Vitamin (Ascorbic Acid) 60 mg Vitamin D3 (Cholecalciferol) 800 IU Vitamin (d-alpha-Tocopherol) 30 IU Biotin 300 mcg MineralsIron (Ferrous Fumarate) 27 mg Zinc (Zinc Sulfate Monohydrate) 10 mg Copper (Cupric Sulfate Anhydrous) mg Docusate Sodium 25 mg.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION:. One softgel daily or as directed by physician.
GENERAL PRECAUTIONS SECTION.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B-12 is deficient.
HOW SUPPLIED SECTION.
HOW SUPPLIED:. TriCare(R) Prenatal DHA ONE(R) Multivitamin/Mineral Softgels for oral administration are supplied as purple softgels, imprinted in gray ink: TriCare DHA 401 in child-resistant plastic bottle of 90 softgels. (NDC 67112-401-90).
INACTIVE INGREDIENT SECTION.
INACTIVE INGREDIENTS:. Gelatin, Glycerol, Hydrogenated Vegetable Oil, Purified Water, Yellow Beeswax, Lecithin, Colloidal Anhydrous Silica, Ethanol, Natural Lime Oil Ordinary 479208/ARTG 1258, Cochineal C175470, Lemon Oil, Titanium Dioxide, Polysorbate 80, Brilliant Blue FCF C142090.