{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. CAUTION Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) daily."],"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 The product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION Prenaissance Balance is a prescription prenatal/postnatal multivitamin/multimineral softgel capsule with DHA. Each softgel is orange in color, opaque and imprinted with \"347\" on one side. SUPPLEMENT FACTS EACH SOFTGEL CONTAINS: Calcium (Calcium citrate) 104 mg Iron (Carbonyl iron) 30 mg Vitamin D 3 (Cholecalciferol) 400 IU Vitamin E (dl-alpha tocopherol acetate) 30 IU Vitamin B 6 (Pyridoxine HCL) 25 mg Folic Acid 1 mg Docusate Sodium 50 mg DHA (Docosahexaenoic Acid) 260 mg OTHER INGREDIENTS Gelatin, Glycerin, Safflower Oil, Lecithin, Purified Water, Yellow Beeswax, Titanium Dioxide, FD&C Yellow #6, Ethyl Vanillin, FD&C Red #40"],"description_table":["
SUPPLEMENT FACTS
EACH SOFTGEL CONTAINS:
Calcium (Calcium citrate) 104 mg
Iron (Carbonyl iron) 30 mg
Vitamin D3 (Cholecalciferol) 400 IU
Vitamin E (dl-alpha tocopherol acetate) 30 IU
Vitamin B6 (Pyridoxine HCL) 25 mg
Folic Acid 1 mg
Docusate Sodium 50 mg
DHA (Docosahexaenoic Acid) 260 mg
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual adult dose is one (1) softgel daily or as directed by a physician. NOTICE Contact with moisture can discolor or erode the capsule."],"effective_time":"20180521","how_supplied":["HOW SUPPLIED Prenaissance Balance is supplied in child-resistant bottles of 30 softgels (42192-347-30). The listed product number is not a National Drug Code. Instead, Acella Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems. Store at 15° - 30°C (59° - 86°F) [See USP]. (Room Temperature) 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. THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE. MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30022 1-800-541-4802 Rev. 0913"],"id":"b9821c75-d893-4bd0-90e3-3bdf0bee955b","indications_and_usage":["INDICATIONS Prenaissance Balance 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."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 42192-347-30 Prenaissance Balance R x Prenatal Vitamin Tablet and DHA Dietary Supplement R x Only 30 Softgels Acella PHARMACEUTICALS, LLC PRINCIPAL DISPLAY PANEL - Prenaissance Balance"],"precautions":["PRECAUTIONS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 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."],"set_id":"e419efba-50db-4a1a-bfd4-541ec10df054","spl_product_data_elements":["Prenaissance Balance CALCIUM CITRATE, IRON, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, DOCONEXENT GELATIN, UNSPECIFIED GLYCERIN SAFFLOWER OIL LECITHIN, SOYBEAN WATER YELLOW WAX TITANIUM DIOXIDE FD&C YELLOW NO. 6 ETHYL VANILLIN FD&C RED NO. 40 CALCIUM CITRATE CALCIUM CATION CALCIUM CITRATE IRON IRON CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE .ALPHA.-TOCOPHEROL PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID DOCUSATE SODIUM DOCUSATE DOCONEXENT DOCONEXENT 347"],"spl_unclassified_section":["R x Only Dietary Supplement"],"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."]}