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. Do not take this product if you are presently taking mineral oil, unless directed by physician.
DESCRIPTION:. Prenaissance Capsules are prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is brown in color, opaqueand imprinted with 341 on one side.. EACH SOFTGEL CONTAINS:Vitamin (ascorbic acid, USP)28 mgCalcium (tricalcium phosphate, NF)160 mgIron (ferrous fumarate, USP)29 mgVitamin D3 (cholecalciferol, USP)800 IUVitamin (d-alpha tocopherol, USP)30 IUVitamin B6 (pyridoxine HCl, USP)25 mgFolic Acid, USP1.25 mgDHA (docosahexaenoic acid)325 mgDocusate Sodium, USP55 mg. OTHER INGREDIENTS:. gelatin, glycerin, purified water, soybean oil, lecithin, yellow bees wax, natural creamy orange flavor, titanium dioxide, FD&C red 40, ethyl vanillin, FD&C yellow 5, 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 Capsules are supplied in child-resistant bottles of 30 softgels (NDC 42192-341-30). Store at 20 25C (68 77F) [See USP].KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
INDICATIONS & USAGE SECTION.
INDICATIONS:. Prenaissance Capsules are multivitamin/multimineral nutritional supplement with DHA indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL 30 Softgels. NDC 42192-341-30Prenaissance CapsulesRx Prenatal Vitamin and DHARx only 30 SoftgelsAcella PHARMACEUTICALS, LLC. PRINCIPAL DISPLAY PANEL 30 Softgels.
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.
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.