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. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
CONTRAINDICATIONS: This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
DESCRIPTION: PNV-Select is prescription prenatal dietary supplement tablet that contains multivitamins and minerals, which are delivered in the form of white, oval, oil-and water-soluble, film-coated tablet debossed with 320 on one side. table. OTHER INGREDIENTS: Dicalcium Phosphate, Cellulose, Croscarmellose Sodium, Stearic Acid, Silicon Dioxide, Magnesium Stearate, Film Coating (Hydroxy Propyl Methyl Cellulose, Triacetin, Titanium Dioxide).
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION: One tablet daily or as directed by physician.
HOW SUPPLIED SECTION.
HOW SUPPLIED: PNV-Select is supplied in child-resistant bottles of 90 tablets (42192-320-90). The listed product is not National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.
INDICATIONS & USAGE SECTION.
INDICATIONS: PNV-Select is multivitamin/multimineral nutritional supplement 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 Film Coated Tablets. NDC 42192-320-90PNV-SelectPrenatal MultivitaminDietary SupplementFilm Coated TabletsRx Only 90 TabletsAcella PHARMACEUTICALS, LLC PNV- Select.
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.
STORAGE AND HANDLING SECTION.
Store at 20-25C (68-77F); excursions permitted to 15-30C (59-86F). [See USP Controlled Room Temperature.].