BOXED WARNING SECTION.
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 immediately. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL - Film Coated Tablets NDC 42192-320-90 PNV-Select Prenatal Multivitamin Dietary Supplement Film Coated Tablets Rx Only 90 Tablets Acella PHARMACEUTICALS, LLC
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
INDICATIONS & USAGE SECTION.
INDICATIONS: PNV-Select is a multivitamin/multimineral nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician.
SPL UNCLASSIFIED SECTION.
All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such persons professional opinion and knowledge, upon evaluating the dietary ingredients, other ingredients and information provided herein. THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE. MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 1-800-541-4802 Rev 0719-03
HOW SUPPLIED SECTION.
HOW SUPPLIED: PNV-Select is supplied in child-resistant bottles of 90 tablets (42192-320-90). The listed product is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems.
DESCRIPTION: PNV-Select is a prescription prenatal dietary supplement tablet that contains multivitamins and minerals, which are delivered in the form of a white, oval, oil-and water-soluble, film-coated tablet debossed with 320 on one side. OTHER INGREDIENTS: Dicalcium Phosphate, Cellulose, Croscarmellose Sodium, Stearic Acid, Silicon Dioxide, Magnesium Stearate, Film Coating (Hydroxy Propyl Methyl Cellulose, Triacetin, Titanium Dioxide).
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.]
CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.