{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Se-Natal 19 Chewable Vitamins and Minerals FOLIC ACID FOLIC ACID .BETA.-CAROTENE .BETA.-CAROTENE CALCIUM ASCORBATE ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM PANTOTHENATE PANTOTHENIC ACID CALCIUM CARBONATE CALCIUM CATION FERROUS FUMARATE FERROUS CATION ZINC OXIDE ZINC CATION ACACIA SILICON DIOXIDE MAGNESIUM STEARATE ORANGE JUICE STEARIC ACID STEVIA REBAUDIUNA LEAF SUCROSE TL015" ], "spl_unclassified_section": [ "A Prescription Prenatal Vitamin with other Vitamins and Minerals for Nutritional Supplementation R x Only", "NOTICE Contact with moisture can discolor or erode the tablet.", "PHARMACIST Dispense in a tight, light-resistant container as defined in the USP/INF with child-resistant closure. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. Reserved for Professional Recommendation. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. R x Only Manufactured For: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 MADE IN CANADA Code 640138 Rev. 03/24 SETON PHARMACEUTICALS" ], "description": [ "DESCRIPTION Se·Natal 19 Chewable tablets are round, debossed \"TL015.\" These tablets provide oil-soluble vitamins, water-soluble vitamins and minerals. Each tablet contains: Supplement Facts ​Servings per Bottle: ​ 100 ​%DV For Pregnant and Lactating Women ​Serving Size 1 chewable tablet ​Each Tablet contains: Vitamin A (as beta carotene) 1000 IU 23% Vitamin C (calcium ascorbate) 100 mg 83% Vitamin D (as cholecalciferol) 10 mcg 67% Vitamin E (as dl-alpha tocopherol acetate) 30 IU 142% Thiamine (Vitamin B 1 ) 3 mg 214% Riboflavin (Vitamin B 2 ​) 3 mg 188% Niacin (as niacinamide) 15 mg 83% Vitamin B 6 (as pyridoxine HCl) 20 mg 1000% Folate (folic acid) 1000 mcg 167% Vitamin B 12 ​ (as cyanocobalamin) 12 mcg 429% Pantothenic Aicd (as calcium pantothenate) 7 mg 100% Calcium (as calcium carbonate) 200 mg 15% Iron (as ferrous fumarate) 29 mg 107% Zinc (as zinc oxide) 20 mg 154%" ], "description_table": [ "
Supplement Facts
​Servings per Bottle:​100​%DV For Pregnant and Lactating Women
​Serving Size1 chewable tablet
​Each Tablet contains:
Vitamin A (as beta carotene)1000 IU23%
Vitamin C (calcium ascorbate)100 mg83%
Vitamin D (as cholecalciferol)10 mcg67%
Vitamin E (as dl-alpha tocopherol acetate)30 IU142%
Thiamine (Vitamin B1)3 mg214%
Riboflavin (Vitamin B2​)3 mg188%
Niacin (as niacinamide)15 mg83%
Vitamin B6 (as pyridoxine HCl)20 mg1000%
Folate (folic acid)1000 mcg167%
Vitamin B12​ (as cyanocobalamin)12 mcg 429%
Pantothenic Aicd (as calcium pantothenate) 7 mg 100%
Calcium (as calcium carbonate)200 mg15%
Iron (as ferrous fumarate)29 mg 107%
Zinc (as zinc oxide) 20 mg 154%
" ], "clinical_pharmacology": [ "​CLINICAL PHARMACOLOGY Oral iron is absorbed most efficiently when administered between meals. Iron is critical for normal hemogloblin syntheis to maintain oxygen transport, energy production and proper function of cells. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes, which are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic acid, which is involved as a cofactor for transformylation reactions in the biosynthesis of purines and thymidylates of nucleic acids. Deficiency of folic acid may account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megablastic macrocytic anemias. Vitamin B ​12 ​ is essential to growth cell reproduction, hematopoiesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia." ], "inactive_ingredient": [ "​OTHER INGREDIENTS Acacia, Fumed Silica, Magnesium Stearate, Natural Orange Flavour, Orange Juice Powder, Stearic Acid, Stevia, Sucrose." ], "indications_and_usage": [ "INDICATIONS AND USAGE Se-Natal 19 Chewable Tablets are indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. Se-Natal 19 Chewable Tablets are also useful in improving the nutritional status of women prior to conception." ], "contraindications": [ "CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients." ], "warnings": [ "WARNINGS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. 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." ], "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 GENERAL Take 2 hours after meals. Do not exceed recommended dose. Discontinue use if symptoms of intolerance appear. ​Folic Acid Folic acid in doses above 0.1 mg daily may obscure pernicious anemia. In that hematologic remission can occur while neurological manifestations remain progressive. ​Pediatric Use Safety and effectiveness in pediatric patients have not been established. ​Geriatric Use Dosing for elderly patients should be cautious. Due to the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, dosing should start at the lower end of the dosing range." ], "adverse_reactions": [ "​ADVERSE REACTIONS Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid." ], "drug_interactions": [ "DRUG INTERACTIONS Prescriber should be aware of a number of iron/drug interactions, including antacids, tetracyclines, or fluoroquinolones." ], "overdosage": [ "OVERDOSAGE Symptoms: Abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock." ], "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION One tablet daily, or as directed by a physician." ], "how_supplied": [ "HOW SUPPLIED Se-Natal 19 Chewable Tablets for oral administration are supplied as multi-color-speckled, round tablets debossed \"TL015,\" packaged in bottles of 100 tablets. Product Code: 13925-117-01" ], "storage_and_handling": [ "STORAGE 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": [ "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 13925-117-01 Se-Natal 19 Chewable Tablets A Prescription Prenatal Vitamin with other Vitamins and Minerals for Nutritional Supplementation R x Only 100 Tablets SETON PHARMACEUTICALS PRINCIPAL DISPLAY PANEL - 100 tablets" ], "set_id": "a54dd642-8884-415a-a082-cd9fb544e400", "id": "b623b8b8-5503-4354-9bfd-4610257ceb87", "effective_time": "20250312", "version": "9", "openfda": { "brand_name": [ "Se-Natal 19 Chewable" ], "generic_name": [ "VITAMINS AND MINERALS" ], "manufacturer_name": [ "Seton Pharmaceuticals" ], "product_ndc": [ "13925-117" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ ".ALPHA.-TOCOPHEROL ACETATE, DL-", ".BETA.-CAROTENE", "CALCIUM ASCORBATE", "CALCIUM CARBONATE", "CALCIUM PANTOTHENATE", "CHOLECALCIFEROL", "CYANOCOBALAMIN", "FERROUS FUMARATE", "FOLIC ACID", "NIACINAMIDE", "PYRIDOXINE HYDROCHLORIDE", "RIBOFLAVIN", "THIAMINE MONONITRATE", "ZINC OXIDE" ], "spl_id": [ "b623b8b8-5503-4354-9bfd-4610257ceb87" ], "spl_set_id": [ "a54dd642-8884-415a-a082-cd9fb544e400" ], "package_ndc": [ "13925-117-01" ], "is_original_packager": [ true ], "nui": [ "M0022797", "N0000175952", "M0022794", "N0000175951" ], "pharm_class_cs": [ "Vitamin D [CS]", "Vitamin B 12 [CS]" ], "pharm_class_epc": [ "Vitamin D [EPC]", "Vitamin B12 [EPC]" ], "unii": [ "WR1WPI7EW8", "183E4W213W", "H0G9379FGK", "568ET80C3D", "1C6V77QF41", "P6YC3EG204", "R5L488RY0Q", "935E97BOY8", "25X51I8RD4", "68Y4CF58BV", "TLM2976OFR", "8K0I04919X", "SOI2LOH54Z" ] } } ] }