{"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 This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION Infanate Balance is a prescription prenatal/postnatal multivitamin/multimineral dietary supplement delivered in the form of a softgel capsule with DHA. Each softgel is dark amber in color, opaque and imprinted with “362” on one side. SUPPLEMENT FACTS EACH SOFTGEL CONTAINS: Calcium (Calcium citrate) 104 mg Iron (Carbonyl iron) 29 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 Docosahexaenoic Acid (DHA) 265 mg OTHER INGREDIENTS: Bovine gelatin, glycerin, soybean oil, soy lecithin, white beeswax, water, sorbitol/sorbitan and caramel. Contains fish and soy."],"description_table":["
SUPPLEMENT FACTS
EACH SOFTGEL CONTAINS:
Calcium (Calcium citrate) 104 mg
Iron (Carbonyl iron) 29 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
Docosahexaenoic Acid (DHA) 265 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":"20180516","how_supplied":["HOW SUPPLIED Infanate Balance is supplied in child-resistant bottles of 30 softgels (42192-362-30). The listed product number is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems. Store at room temperature, approximately 15° - 30°C (59° - 86°F). Avoid excessive heat. 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 dietary ingredients, other ingredients and 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.0613"],"id":"8c09bfb7-bacb-41c8-9044-312bf756de2a","indications_and_usage":["INDICATIONS Infanate Balance is a multivitamin/ mineral prescription dietary supplement 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 - 30 Softgels NDC 42192-362-30 Infanate Balance R x Prenatal Vitamin and DHA R x only 30 Softgels Acella PHARMACEUTICALS, LLC 30 Softgels"],"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."],"set_id":"f4536d00-3940-48b6-a2d1-54e5e6d17f24","spl_product_data_elements":["Infanate Balance CALCIUM CITRATE, IRON, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, DOCUSATE SODIUM, DOCONEXENT GELATIN, UNSPECIFIED GLYCERIN SOYBEAN OIL LECITHIN, SOYBEAN WHITE WAX WATER SORBITOL CARAMEL 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 dark amber 362"],"spl_unclassified_section":["Rx Only"],"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.","WARNING Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient."]}