{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-01", "results": { "skip": 0, "limit": 1, "total": 15 } }, "results": [ { "spl_product_data_elements": [ "PNV-DHA ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, magnesium, doconexent CARNAUBA WAX CORN OIL LECITHIN, SOYBEAN GELATIN GLYCERIN WATER TITANIUM DIOXIDE FD&C BLUE NO. 1 FD&C RED NO. 3 ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- PYRIDOXINE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CALCIUM FERROUS FUMARATE FERROUS CATION MAGNESIUM MAGNESIUM DOCONEXENT DOCONEXENT BP;321" ], "spl_unclassified_section": [ "Rx Only", "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 9005 Westside Parkway Alpharetta, GA 30009 1-800-541-4802 Rev. 04/10v6 *Xolafin-B™ is a trademark of Acella Pharmaceuticals, LLC" ], "description": [ "DESCRIPTION: PNV-DHA is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is blue in color, opaque and imprinted with “BP 321” on one side. Supplement Facts Serving Size 1 Tablet Amount Per Serving % DV %DV for Pregnant or Lactating Women Vitamin C 85 mg 142% 142% Vitamin D 3 200 IU 50% 50% Vitamin E 10 IU 33% 33% Vitamin D 6 25 mg 1250% 1000% Folate 1 mg 250% 125% (L-methylfolate calcium 676 mcg (as Xolafin-B™ Percent Daily Values are based on a 2000 calorie diet ) molar equivalent to 600 mcg of Folic Acid) (folic acid, USP 400 mcg) Vitamin B 12 12 mcg 200% 150% Calcium 140 mg 14% 11% Iron (ferrous fumarate) 27 mg 150% 150% Magnesium 45 mg 11% 10% Docosahexaenoic Acid (DHA) (from omega-3 fatty acids) 300 mg Daily Value (DV) not established OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3. INDICATIONS: PNV-DHA 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. CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients." ], "description_table": [ "
Supplement Facts
Serving Size 1 Tablet
Amount Per Serving % DV %DV for Pregnant or Lactating Women
Vitamin C85 mg142%142%
Vitamin D 3200 IU50%50%
Vitamin E10 IU33%33%
Vitamin D 625 mg1250%1000%
Folate1 mg250%125%
(L-methylfolate calcium 676 mcg (as Xolafin-B™ Percent Daily Values are based on a 2000 calorie diet) molar equivalent to 600 mcg of Folic Acid)
(folic acid, USP 400 mcg)
Vitamin B 1212 mcg200%150%
Calcium140 mg14%11%
Iron (ferrous fumarate)27 mg150%150%
Magnesium45 mg11%10%
Docosahexaenoic Acid (DHA) (from omega-3 fatty acids) 300 mgDaily Value (DV) not established
" ], "inactive_ingredient": [ "OTHER INGREDIENTS: bee’s wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue #1, FD&C Red #3." ], "indications_and_usage": [ "INDICATIONS: PNV-DHA 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." ], "contraindications": [ "CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients." ], "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." ], "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." ], "precautions": [ "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." ], "adverse_reactions": [ "ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid." ], "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician." ], "how_supplied": [ "HOW SUPPLIED: PNV-DHA is supplied in child-resistant bottles of 30 softgels (NDC# 42192-321-30). Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets NDC 42192-321-30 PNV-DHA Rx Prenatal Vitamin and DHA Rx Only 30 Softgels Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - Film Coated Tablets" ], "set_id": "038fe2e7-dc16-485c-b5fb-746db7231347", "id": "973ff5d8-ba4b-4641-a3a0-3840e4630ce3", "effective_time": "20240115", "version": "3", "openfda": { "brand_name": [ "PNV-DHA" ], "generic_name": [ "ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERROUS FUMARATE, MAGNESIUM, DOCONEXENT" ], "manufacturer_name": [ "Acella Pharmaceuticals, LLC" ], "product_ndc": [ "42192-321" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ ".ALPHA.-TOCOPHEROL ACETATE, DL-", "ASCORBIC ACID", "CALCIUM", "CHOLECALCIFEROL", "CYANOCOBALAMIN", "DOCONEXENT", "FERROUS FUMARATE", "FOLIC ACID", "MAGNESIUM", "PYRIDOXINE" ], "spl_id": [ "973ff5d8-ba4b-4641-a3a0-3840e4630ce3" ], "spl_set_id": [ "038fe2e7-dc16-485c-b5fb-746db7231347" ], "package_ndc": [ "42192-321-30" ], "is_original_packager": [ true ], "nui": [ "N0000193618", "M0001797", "M0003153", "N0000175901", "M0022797", "N0000175952", "M0022794", "N0000175951", "N0000192800", "N0000005657", "N0000175452" ], "pharm_class_epc": [ "Vitamin C [EPC]", "Calcium [EPC]", "Vitamin D [EPC]", "Vitamin B12 [EPC]", "Vitamin B6 Analog [EPC]" ], "pharm_class_cs": [ "Ascorbic Acid [CS]", "Calcium [CS]", "Vitamin D [CS]", "Vitamin B 12 [CS]", "Vitamin B 6 [Chemical/Ingredient]", "Analogs/Derivatives [Chemical/Ingredient]" ], "unii": [ "WR1WPI7EW8", "PQ6CK8PD0R", "SY7Q814VUP", "1C6V77QF41", "P6YC3EG204", "ZAD9OKH9JC", "R5L488RY0Q", "935E97BOY8", "I38ZP9992A", "KV2JZ1BI6Z" ] } } ] }