{"adverse_reactions":["ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"contraindications":["CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"description":["DESCRIPTION: PRENATE CHEWABLE ® is a prescription prenatal/postnatal multivitamin/mineral chocolate chewable tablet. Each tablet is brown and imprinted with “Prenate Chew” on one side and blank on the other. OTHER INGREDIENTS: Cocoa powder, magnesium stearate, maltodextrin, modified food starch, natural milk chocolate flavor, silica, stearic acid, and sucrose. THIS PRODUCT MAY CONTAIN SOY. Prenate Chewable SF Panel"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: One tablet daily or as directed by a physician."],"effective_time":"20251125","how_supplied":["HOW SUPPLIED: PRENATE CHEWABLE ® is supplied in child-resistant bottles of 30 tablets (75854-306-30). The listed product number is not a National Drug Code, but has instead merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems. Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature.] 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: Avion Pharmaceuticals, LLC Alpharetta, GA 30005 1-800-541-4802 L-0159 Rev. 1025-03 *Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662 CAS# 1181972-37-1."],"id":"446d4734-3924-b589-e063-6394a90ab23f","indications_and_usage":["INDICATIONS: PRENATE CHEWABLE ® is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PRENATE CHEWABLE ® can also be beneficial in improving the nutritional status of women prior to conception."],"openfda":{"brand_name":["Prenate Chewable"],"generic_name":["CALCIUM CARBONATE, CHOLECALCIFEROL, MAGNESIUM OXIDE, BORON, FOLIC ACID, LEVOMEFOLATE GLUCOSAMINE, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN AND BLUEBERRY"],"is_original_packager":[true],"manufacturer_name":["Avion Pharmaceuticals, LLC"],"nui":["M0022797","N0000175952","M0022794","N0000175951"],"package_ndc":["75854-306-30"],"pharm_class_cs":["Vitamin D [CS]","Vitamin B 12 [CS]"],"pharm_class_epc":["Vitamin D [EPC]","Vitamin B12 [EPC]"],"product_ndc":["75854-306"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["446d4734-3924-b589-e063-6394a90ab23f"],"spl_set_id":["917f02ce-51b9-4819-81e0-522842f6732a"],"substance_name":["CALCIUM CARBONATE","CHOLECALCIFEROL","MAGNESIUM OXIDE","BORON","FOLIC ACID","PYRIDOXINE HYDROCHLORIDE","CYANOCOBALAMIN","BIOTIN","BLUEBERRY","LEVOMEFOLATE GLUCOSAMINE"],"unii":["H0G9379FGK","1C6V77QF41","3A3U0GI71G","N9E3X5056Q","935E97BOY8","68Y4CF58BV","P6YC3EG204","6SO6U10H04","253RUG1X1A","Q65PL71Q1A"],"upc":["0375854306302"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL 75854-306-30 Prenate chewable ® A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic® Dietary Supplement 30 Tablets Rx Only Avion Pharmaceuticals Prenate Chewable Bottle Label"],"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. Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic test (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin. While prescribing this nutritional supplement for pregnant women, nursing mothers or for women prior to conception, their medical condition and other drugs, herbs and/or supplements consumption should be considered."],"set_id":"917f02ce-51b9-4819-81e0-522842f6732a","spl_product_data_elements":["Prenate Chewable calcium carbonate, cholecalciferol, magnesium oxide, boron, folic acid, levomefolate glucosamine, pyridoxine hydrochloride, cyanocobalamin, biotin and blueberry MAGNESIUM STEARATE MALTODEXTRIN SILICA STEARIC ACID SUCROSE MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) COCOA CALCIUM CARBONATE CALCIUM CATION CHOLECALCIFEROL CHOLECALCIFEROL MAGNESIUM OXIDE MAGNESIUM CATION BORON BORON FOLIC ACID FOLIC ACID PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN BIOTIN BIOTIN BLUEBERRY BLUEBERRY LEVOMEFOLATE GLUCOSAMINE LEVOMEFOLATE GLUCOSAMINE PrenateChew"],"version":"10"}