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 childrenunder 6. Keep this product out of reach of children. In case of accidental overdose, call doctor or poison control center immediately.

CONTRAINDICATIONS SECTION.


CONTRAINDICATIONS:. This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

DESCRIPTION SECTION.


DESCRIPTION:. Prenaissance Plus is prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is purple in color, opaque and imprinted with 343 on one side.. EACH SOFTGEL CONTAINS:Calcium (Calcium citrate)100 mgIron (Carbonyl Iron)28 mgVitamin D3 (Cholecalciferol)400 IUVitamin (dl-alpha tocopherol acetate)30 IUVitamin B6 (Pyridoxine HCI)25 mgFolic Acid1 mgDocusate Sodium50 mgDHA (Docosahexaenoic acid)250 mg. OTHER INGREDIENTS:. soybean oil, yellow bees wax, lecithin, natural orange cream flavoring, gelatin, glycerine, purified water, carmine, titanium dioxide, ethyl vanillin, FD&C40, and FD&C Blue 1.

DOSAGE & ADMINISTRATION SECTION.


DOSAGE AND ADMINISTRATION:. Usual adult dose is (one) softgel daily or as directed by physician.

HOW SUPPLIED SECTION.


HOW SUPPLIED:. Prenaissance Plus is supplied in child-resistant bottles of 30 softgels (NDC 42192-343-30). Store at 15 30C (59 86F) [See USP].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

INDICATIONS & USAGE SECTION.


INDICATIONS:. Prenaissance Plus is multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 30 Softgels. NDC 42192-343-30Prenaissance Plus Rx Prenatal Vitamin and DHARx only 30 SoftgelsAcella PHARMACEUTICALS, LLC. PRINCIPAL DISPLAY PANEL 30 Softgels.

PRECAUTIONS SECTION.


PRECAUTIONS:. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

WARNINGS SECTION.


WARNING:. Ingestion of more than grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including anincreased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.