{ "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": "2026-06-03", "results": { "skip": 0, "limit": 1, "total": 43 } }, "results": [ { "spl_product_data_elements": [ "CitraNatal Assure ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper, docusate sodium, doconexent and icosapent Prenatal Vitamin ascorbic acid, calcium citrate, iron, vitamin d, dl- alpha- tocopherol acetate, thiamine, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, iodine, zinc, copper and docusate sodium POVIDONE K30 CROSCARMELLOSE SODIUM TITANIUM DIOXIDE MAGNESIUM SILICATE MAGNESIUM STEARATE SHELLAC VANILLIN ASCORBIC ACID ASCORBIC ACID IRON IRON CHOLECALCIFEROL CHOLECALCIFEROL ALPHA-TOCOPHEROL ALPHA-TOCOPHEROL RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID IODINE IODINE ZINC ZINC COPPER COPPER DOCUSATE SODIUM DOCUSATE THIAMINE THIAMINE ION CALCIUM CITRATE CALCIUM CATION CALCIUM CITRATE ANHYDROUS 0891 DHA doconexent and icosapent GELATIN SUNFLOWER OIL GLYCERIN LECITHIN, SUNFLOWER ROSEMARY TOCOPHEROL ASCORBYL PALMITATE DOCONEXENT DOCONEXENT ICOSAPENT ICOSAPENT caramel color" ], "description": [ "DESCRIPTION CitraNatal Assure ® is a prescription prenatal/postnatal multivitamin/mineral tablet with Ferr-Ease ® , a patented dual-iron delivery comprising both a quick release and slow release iron, and a capsule of an essential fatty acid. The prenatal vitamin is a white, coated, oval multivitamin/mineral tablet. The tablet is debossed \"0891\" on one side and is blank on the other. The essential fatty acid DHA capsule is caramel colored and contains a light yellow to orange semi-solid mixture. Each prenatal capsule contains: Vitamin C (Ascorbic acid) 120 mg Calcium (Calcium citrate) 124 mg Iron (Carbonyl iron, ferrous gluconate) 35 mg Vitamin D 3 (Cholecalciferol) 400 IU Vitamin E (dl-alpha tocopheryl acetate) 30 IU Thiamin (Vitamin B 1 ) 3 mg Riboflavin (Vitamin B 2 ) 3.4 mg Niacinamide (Vitamin B 3 ) 20 mg Vitamin B 6 (Pyridoxine HCl) 25 mg Folic Acid 1 mg Iodine (Potassium iodide) 150 mcg Zinc (Zinc oxide) 25 mg Copper (Cupric oxide) 2 mg Docusate Sodium 50 mg Each DHA gelatin capsule contains: Docosahexaenoic Acid (DHA, 40% from 750 mg Algal Oil) 300 mg Eicosapentaenoic Acid (EPA) Not more than 0.750 mg Other ingredients in DHA gelatin capsule: Gelatin, sunflower oil, glycerin, caramel color, sunflower lecithin, rosemary extract, tocopherols, ascorbyl palmitate." ], "description_table": [ "
Each prenatal capsule contains:
Vitamin C (Ascorbic acid)120 mg
Calcium (Calcium citrate)124mg
Iron (Carbonyl iron, ferrous gluconate)35 mg
Vitamin D 3(Cholecalciferol) 400 IU
Vitamin E (dl-alpha tocopheryl acetate)30 IU
Thiamin (Vitamin B 1) 3 mg
Riboflavin (Vitamin B 2) 3.4 mg
Niacinamide (Vitamin B 3) 20 mg
Vitamin B 6(Pyridoxine HCl) 25 mg
Folic Acid1 mg
Iodine (Potassium iodide)150 mcg
Zinc (Zinc oxide)25 mg
Copper (Cupric oxide)2 mg
Docusate Sodium50 mg
Each DHA gelatin capsule contains:
Docosahexaenoic Acid (DHA, 40% from 750 mg Algal Oil)300 mg
Eicosapentaenoic Acid (EPA)Not more than 0.750 mg
" ], "indications_and_usage": [ "INDICATIONS CitraNatal Assure ® is a multivitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers." ], "contraindications": [ "CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients." ], "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 THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately." ], "warnings": [ "WARNING Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.", "WARNING Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient." ], "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." ], "adverse_reactions": [ "ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid." ], "dosage_and_administration": [ "DOSAGE AND ADMINISTRATION One tablet and one capsule daily or as directed by a physician." ], "spl_unclassified_section": [ "CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.", "To report a serious adverse event or obtain product information, call (210) 696-8400. 51062R1120 MISSION ® PHARMACAL DHA capsules manufactured for: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355 Prenatal tablets manufactured by: MISSION PHARMACAL COMPANY San Antonio, TX USA 78230 1355 Copyright © 2020 Mission Pharmacal Company. All rights reserved." ], "storage_and_handling": [ "STORAGE Store at 20–25°C (68–77°F) NOTICE Contact with moisture can discolor or erode the tablet." ], "how_supplied": [ "Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0891-30" ], "package_label_principal_display_panel": [ "CitraNatal Assure Retail Blister Pack NDC 0178–0891–30 Retail Blister", "Retail Carton Label" ], "set_id": "06c529fc-272c-f889-f5e5-7f3e5ef2c59d", "id": "47e8233b-c64c-b42d-e063-6294a90a14e3", "effective_time": "20260108", "version": "12", "openfda": { "brand_name": [ "CitraNatal Assure" ], "generic_name": [ "ASCORBIC ACID, CALCIUM CITRATE, IRON, VITAMIN D, DL- ALPHA- TOCOPHEROL ACETATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, IODINE, ZINC, COPPER, DOCUSATE SODIUM, DOCONEXENT AND ICOSAPENT" ], "manufacturer_name": [ "Mission Pharmacal Company" ], "product_ndc": [ "0178-0891" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "1535150" ], "spl_id": [ "47e8233b-c64c-b42d-e063-6294a90a14e3" ], "spl_set_id": [ "06c529fc-272c-f889-f5e5-7f3e5ef2c59d" ], "package_ndc": [ "0178-0891-30" ], "is_original_packager": [ true ], "upc": [ "0301780891308" ] } } ] }