{"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."],"description":["Description Folplex™ tablets are intended for oral administration. Each Tablet Contains: 2.2 mg folic acid, 25 mg Vitamin B 6 and 1 mg Vitamin B 12 . INACTIVE INGREDIENTS: Dibasic Calcium Phosphate, Microcrystalline Cellulose, Modified Cellulose Gum, Crospovidone, Magnesium Stearate, Hypromellose, Titanium Dioxide, Polydextrose, Triacetin, Polyethylene Glycol, Iron Oxide Red, Iron Oxide Yellow."],"dosage_and_administration":["Dosage and Administration Adults - one tablet daily or as directed by a physician."],"effective_time":"20120615","how_supplied":["How Supplied Folplex™ tablets are peach color coated oval-shaped tablets. Each tablet is imprinted with B 352 on the scored side and plain on the other side. Folplex™ tablets are available in bottles of 100 tablets. NDC 51991-352-01 All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. Dispense in a tight, light-resistant container with a child-resistant closure, as defined in USP/NF. Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). See USP Controlled Room Temperature. Protect from light and moisture."],"id":"2b7cf9c2-9bde-4ba5-b23d-45e8cf0cef94","indications_and_usage":["Indications and Usage Folplex™ tablets are indicated for nutritional support and folic acid supplementation."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 100 Tablets Bottle Breckenridge Pharmaceutical, Inc. NDC 51991-352-01 Folplex™ Each Tablet Contains: Folic Acid ........................... 2.2 mg Vitamin B 6 .......................... 25 mg Vitamin B 12 .......................... 1 mg Rx Only 100 Tablets Principal Display Panel - 100 Tablets Bottle"],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"precautions":["Precautions Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"set_id":"5e01648a-51aa-477e-abb8-04b0e34f349d","spl_product_data_elements":["Folplex Folic Acid, Cholecalciferol and Pyridoxine Hydrochloride Folic Acid Folic Acid Cholecalciferol Cholecalciferol Pyridoxine Hydrochloride Pyridoxine Calcium Phosphate, Dibasic, Dihydrate Cellulose, Microcrystalline Croscarmellose Sodium Crospovidone Magnesium Stearate Hypromelloses Titanium Dioxide Polydextrose Triacetin Polyethylene Glycols Ferric Oxide Red Ferric Oxide Yellow B;352"],"spl_unclassified_section":["Manufactured by: Nexgen Pharma, Inc. Irvine, CA 92614 Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487 Rx Only 7047 Rev. 11/08"],"storage_and_handling":["Dispense in a tight, light-resistant container with a child-resistant closure, as defined in USP/NF. Store at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F). See USP Controlled Room Temperature. Protect from light and moisture."],"version":"4","warnings":["Warning Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately."]}