{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid, however, no allergic sensitization has been reported with the use of Xolafin-B™."],"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-DHA Plus is a prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is blue in color, opaque and imprinted with “315” on one side. EACH SOFTGEL CONTAINS: L-methylfolate calcium (as Xolafin-B™)..............1.13 mg Calcium (tricalcium phosphate)..............................75 mg Elemental Iron (ferrous fumarate)...........................27 mg Vitamin C (ascorbic acid).....................................40 mg Vitamin E (D-alpha tocopherol)..........................30 IU Vitamin B 6 (pyridoxine HCL)..........................25 mg Vitamin B 9 (folic acid)......................................400 mcg Vitamin B 12 (methylcobalamin).............................1 mg Docosahexaenoic Acid (DHA)................................250 mg OTHER INGREDIENTS bee's wax, hydrogenated vegetable shortening, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3, Sugar, lactose, yeast and gluten free. INDICATIONS PNV-DHA Plus is a multivitamin/multimineral with DHA 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 Usual adult dose is 1 (one) softgel 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 levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both 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":"20180521","how_supplied":["HOW SUPPLIED PNV-DHA Plus is supplied in child-resistant bottles of 30 softgels (NDC# 42192-315-30). Store at 15° - 30°C (59° - 86°F) [See USP]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. 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 status or bioequivalency. 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 Alpharetta, GA 30009 1-800-541-4802 Rev. 0810v3"],"id":"bc420846-59ba-450f-b77f-6171e853d80e","inactive_ingredient":["OTHER INGREDIENTS bee's wax, hydrogenated vegetable shortening, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3, Sugar, lactose, yeast and gluten free."],"indications_and_usage":["INDICATIONS PNV-DHA Plus is a multivitamin/multimineral with DHA 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 - 30 Softgels 42192-315-30 PNV-DHA Plus Daily Prenatal Vitamin and DHA R x Only 30 Softgels Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - Film Coated Tablets"],"precautions":["PRECAUTIONS Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress."],"set_id":"ee30cd84-c3a2-4de9-b976-f45546564512","spl_product_data_elements":["PNV-DHA PLUS LEVOMEFOLATE CALCIUM, TRICALCIUM PHOSPHATE, FERROUS FUMARATE, ASCORBIC ACID, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, METHYLCOBALAMIN, DOCONEXENT YELLOW WAX SOYBEAN OIL LECITHIN, SOYBEAN GELATIN, UNSPECIFIED GLYCERIN WATER TITANIUM DIOXIDE FD&C BLUE NO. 1 FD&C RED NO. 3 SUCROSE LACTOSE, UNSPECIFIED FORM YEAST, UNSPECIFIED GLUTENIN LEVOMEFOLATE CALCIUM LEVOMEFOLIC ACID TRICALCIUM PHOSPHATE CALCIUM CATION FERROUS FUMARATE FERROUS CATION ASCORBIC ACID ASCORBIC ACID .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID METHYLCOBALAMIN METHYLCOBALAMIN DOCONEXENT DOCONEXENT 315"],"spl_unclassified_section":["Rx Only","PHARMACOLOGY L-methylfolate 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 teh blood brain barrier. In the cell, 6(S)-5-MTHF is used in methylation of homosysteine to form methionine and tetrahydrofolate (THF). THF is the immediate acceptor of one carbon unit for the synthesis of thymidine-DHNA, purines (RNA and DNA) and methionine. 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. Docosahexaenoic Acid Docosahexaenoic acid or DHA, is a long-chain polyunsaturated omega-3 fatty acid (C22:6n-3). DHA is an indespensable component of all cell membranes and is incorporated in high concentrations in the membrane phospholipids of brain and retina."],"version":"1","warnings":["WARNING Ingestion of more than 3 grams of omega- 3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased 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."]}