{"adverse_reactions":["Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"description":["CitraNatal Bloom™ DHA is a prescription prenatal/postnatal multi-vitamin/mineral tablet with Ferr-Ease®, a patented dual-iron delivery comprising both a quick release and slow release iron, and a soft gel of DHA, an essential fatty acid. The prenatal vitamin is a green, modified rectangle shaped, film-coated tablet, debossed with “CB” on one side and blank on the other. The essential fatty acid DHA soft gel is oblong, light brown and contains a yellow to orange fill. Each prenatal tablet contains: Iron (Carbonyl iron, ferrous gluconate)...........................90 mg Folic Acid .........................................................................1 mg Vitamin B12 (Cyanocobalamin) ...................................12 mcg Vitamin C (Ascorbic acid).............................................120 mg Docusate sodium ..........................................................50 mg"],"dosage_and_administration":["One tablet and one soft gel daily or as directed by a physician."],"effective_time":"20200406","how_supplied":["Six child-resistant blister packs of 5 tablets and 5 soft gels each – NDC 0178-00816-30."],"id":"a2a1c709-8dd2-44c5-e053-2995a90a1490","inactive_ingredient":["Povidone, croscarmellose sodium, acrylic resin, color added, FD&C Yellow No. 5, magnesium stearate, magnesium silicate, FD&C Blue No. 1, polyethylene glycol, vitamin A palmitate, ethyl vanillin."],"indications_and_usage":["CitraNatal Bloom DHA is a multi-vitamin/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."],"openfda":{},"package_label_principal_display_panel":["","Six child-resistant blister packs of 5 tablets and 5 capsules each - NDC 0178-0816-30 CitraNatal Bloom DHA blister","Retail Carton Retail Carton"],"set_id":"63004034-123d-c9c8-e053-2991aa0a359a","spl_product_data_elements":["CitraNatal Bloom DHA iron, folic acid, cyanocobalamin, ascorbic acid, docusate sodium and DHA Prenatal iron, folic acid, cyanocobalamin, ascorbic acid, and docusate sodium MAGNESIUM SILICATE VITAMIN A PALMITATE ETHYL VANILLIN FD&C BLUE NO. 1 POLYETHYLENE GLYCOL 8000 FD&C YELLOW NO. 5 MAGNESIUM STEARATE TITANIUM DIOXIDE DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER POVIDONE ASCORBIC ACID ASCORBIC ACID FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN FERROUS GLUCONATE FERROUS CATION IRON PENTACARBONYL FERROUS CATION DOCUSATE SODIUM DOCUSATE CB;blank Coated Tablet Modified Rectangle DHA DHA ICOSAPENT SUNFLOWER OIL ROSEMARY ASCORBYL PALMITATE LECITHIN, SUNFLOWER TOCOPHEROL CRYPTHECODINIUM COHNII DHA OIL CRYPTHECODINIUM COHNII DHA OIL none Soft gelatin capsule Soft gelatin capsule"],"spl_unclassified_section":["To report a serious adverse event or obtain product information, call (800) 298-1087. MISSION PHARMACAL COMPANY, San Antonio, TX 78230 1355 51080R0717 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 © 2017 Mission Pharmacal Company. All rights reserved. www.missionpharmacal.com Ferr-Ease ® Dual-iron delivery Trademark of Mission Pharmacal Company U.S. Patent No. 6,521,247 life's DHA ® life’sDHA is a trademark of DSM. U.S. Patent No. 7,579,174 U.S. Patent No. 7,732,170 U.S. Patent No. 5,518,918 *March of Dimes does not endorse specific products or brands. March of Dimes is a registered trademark of the March of Dimes Foundation."],"storage_and_handling":["STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. NOTICE: Contact with moisture can discolor or erode the tablet."],"version":"3","warnings_and_cautions":["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. 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 B12 is deficient. PRECAUTIONS: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. CAUTION: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day. Please consult your health care provider with any dietary concerns."]}