{"adverse_reactions":["ADVERSE REACTIONS While allergic sensitization has been reported following both oral and paranteral administration of folic acid, allergic sensitization has not been reported with the use of Xolafin-B™. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with cyanocobalamin."],"boxed_warning":["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."],"contraindications":["CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION PNV - Iron is a nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation. EACH TABLET CONTAINS: L-Methylfolate Calcium (as Xolafin-B ™* )........................................1.13 mg Vitamin B 6 (pyridoxine as pyridoxine HCl)........................................2.6 mg Iron (as polysaccharide iron complex).................................................29 mg Vitamin B 9 (folic acid)........................................................................0.4 mg Vitamin C (ascorbic acid)...................................................................80 mg Vitamin B 12 (cyanocobalamin)..........................................................0.5 mg Vitamin D 3 (cholecalciferol)...............................................................400 IU Biotin...................................................................................................0.03 mg Vitamin E (dl-alpha tocopherol acetate)................................................30 IU Copper (copper oxide)..........................................................................2 mg Vitamin B 1 (thiamine as thiamine mononitrate).....................................3 mg Zinc (as zinc oxide).............................................................................15 mg Vitamin B 2 (riboflavin )......................................................................3.4 mg Calcium (calcium carbonate)............................................................200 mg Vitamin B 3 (niacinamide)...................................................................20 mg Magnesium (as magnesium oxide).....................................................40 mg Vitamin B 5 (pantothenic acid as d-calcium pantothenate).....................7 mg OTHER INGREDIENTS dicalcium phosphate, microcrystalline cellulose, stearic acid, croscarmellose sodium, silica, magnesium stearate, aqueous coating, titanium dioxide, FD&C Red 40. PNV - Iron tablets do not contain lactose, yeast or gluten. INDICATIONS PNV - Iron is a nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation. CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One tablet daily or as directed by a physician."],"drug_interactions":["DRUG INTERACTIONS Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levadopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing carbidopa and levodopa. While the concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness, no such decreased effectiveness has been reported with the use of Xolafin-B™. Capecitabine (Xeloda ® ) toxicity may increase with the addition of leucovorin (5-formyltetrahydrofolate) (folate)."],"effective_time":"20180604","how_supplied":["HOW SUPPLIED PNV - Iron is an oval, pink-colored tablet debossed with “314” on one side and is supplied in child-resistant bottles of 90 tablets (NDC# 42192-314-90). Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.] All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. Please 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 or therapeutic equivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical information provided herein. MANUFACTURED FOR: Acella Pharmaceuticals, LLC 9005 Westside Parkway Alpharetta, GA 30009 1-800-541-4802 Rev. 0810v2 * Xolafin-B™ is a trademark of Acella Pharmaceuticals, LLC."],"id":"65c05316-6bdd-49e0-a53a-ddd4ed020c80","inactive_ingredient":["OTHER INGREDIENTS dicalcium phosphate, microcrystalline cellulose, stearic acid, croscarmellose sodium, silica, magnesium stearate, aqueous coating, titanium dioxide, FD&C Red 40. PNV - Iron tablets do not contain lactose, yeast or gluten."],"indications_and_usage":["INDICATIONS PNV - Iron is a nutritional supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 90 Tablets NDC 42192-314-90 PNV - Iron Prenatal Vitamin Rx Only 90 Tablets Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL"],"patient_medication_information":["PATIENT INFORMATION PNV - Iron is a nutritional supplement for use only under the direction and supervision of a licensed physician."],"precautions":["PRECAUTIONS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient. Folates in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress."],"set_id":"58674df6-0e88-4052-9a4f-7c5c1cff06fe","spl_product_data_elements":["PNV-IRON LEVOMEFOLATE CALCIUM, PYRIDOXINE HYDROCHLORIDE, IRON, FOLIC ACID, ASCORBIC ACID, CYANOCOBALAMIN, CHOLECALCIFEROL, BIOTIN, .ALPHA.-TOCOPHEROL ACETATE, DL-, CUPRIC OXIDE, THIAMINE MONONITRATE, ZINC OXIDE, RIBOFLAVIN, CALCIUM CARBONATE, NIACINAMIDE, MAGNESIUM OXIDE, PANTOTHENIC ACID ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE STEARIC ACID CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE TITANIUM DIOXIDE FD&C RED NO. 40 LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE IRON IRON FOLIC ACID FOLIC ACID ASCORBIC ACID ASCORBIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CHOLECALCIFEROL CHOLECALCIFEROL BIOTIN BIOTIN .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- CUPRIC OXIDE CUPRIC CATION THIAMINE MONONITRATE THIAMINE ION THIAMINE ZINC OXIDE ZINC OXIDE RIBOFLAVIN RIBOFLAVIN CALCIUM CARBONATE CALCIUM CATION NIACINAMIDE NIACINAMIDE MAGNESIUM OXIDE MAGNESIUM CATION PANTOTHENIC ACID PANTOTHENIC ACID 314"],"spl_unclassified_section":["Rx Only","KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.","PHARMACOLOGY L-methylfolate or 6(S)-5 methyltetrahydrofolate [6(S)-5 MTHF], is the primary biologically active isomer of folate and the form of folate in circulation. It is also the form which is transported across membranes into peripheral tissues, particularly across the blood brain barrier. In the cell, 6(S)-5 MTHF is used in the methylation of homocysteine to form methionine and tetrahydrofolate (THF). THF is the immediate acceptor of one carbon units for the synthesis of thymidine-DNA, purines (RNA and DNA) and methionine. About 70% of food folate and cellular folate is comprised of 6(S)-5 MTHF. Folic acid, the synthetic form of folate, must undergo enzymatic reduction by methylenetetrahydrofolate reductase (MTHFR) to become biologically active. Genetic mutations of MTHFR result in a cell's inability to convert folic acid to 6(S)-5 MTHF."],"version":"3"}