{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"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 All iron compounds are contraindicated in patients with hemochromatosis and hemosiderosis. This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["Each Vinacal™ tablet contains: Vitamin C (as Ascorbic Acid)...........................................................120 mg Vitamin D 3 (Cholecalciferol) .............................................................400 IU Vitamin E (as dl-Alpha Tocopheryl Acetate).......................................30 IU Vitamin B 1 (as Thiamine Mononitrate) ................................................3 mg Vitamin B 2 (Riboflavin) .....................................................................3.4 mg Niacinamide (Vitamin B 3 ) ..................................................................20 mg Vitamin B 6 (as Pyridoxine HCl) .........................................................20 mg Folic Acid ............................................................................................1 mg Calcium (as Calcium Citrate) ..........................................................125 mg Iron (as Carbonyl Iron and Ferrous Gluconate) ................................27 mg Iodine (as Potassium Iodide).........................................................150 mcg Zinc (as Zinc Oxide) ..........................................................................25 mg Copper (as Cupric Oxide) ...................................................................2 mg Docusate Sodium .............................................................................50 mg Inactive Ingredients: Citric Acid, Croscarmellose Sodium, Crospovidone, Dicalcium Phosphate, Gelatin, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Polyvinylpyrrolidone, Silica, Sodium Ascorbate, Sodium Benzoate, Sodium Lauryl Sulfate, Sorbic Acid, Soy Polysaccharide, Starch, Stearic Acid, Sucrose, Titanium Dioxide, Triacetin, Triglycerides and Tocopherols. Allergen: Contains Soy"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adults only One tablet daily, or as directed by a physician."],"effective_time":"20110107","how_supplied":["HOW SUPPLIED Vinacal™ Tablets are available as a scored, white film-coated, oval shaped tablet debossed B 617 on one side and blank on the other. Supplied in bottles of 90, NDC 51991-617-90. 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. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product."],"id":"fd02bd8b-f724-41ba-a468-3a98ab9641fc","indications_and_usage":["INDICATIONS Vinacal™ Tablets are a multivitamin/multimineral tablet, for use in supplementing 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 - 90 Tablet Bottle Breckenridge Pharmaceutical, Inc. NDC 51991-617-90 Vinacal™ Prenatal Tablets DO NOT USE IF SAFETY SEAL UNDER THE CAP IS BROKEN OR MISSING Rx Only 90 TABLETS Principal Display Panel - 90 Tablet Bottle"],"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."],"set_id":"56877685-78fa-43df-926c-030a8f28d709","spl_product_data_elements":["Vinacal Docusate Sodium, Ascorbic Acid, .ALPHA.-TOCOPHEROL ACETATE, DL-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cholecalciferol, Calcium Citrate, Iron, Potassium Iodide, Zinc Oxide, and Cupric Oxide Docusate Sodium Docusate Ascorbic Acid Ascorbic Acid .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL ACETATE, DL- Thiamine Mononitrate Thiamine Riboflavin Riboflavin Niacinamide Niacin Pyridoxine Hydrochloride Pyridoxine Folic Acid Folic Acid Cholecalciferol Cholecalciferol Calcium Citrate Calcium Iron Iron Potassium Iodide Iodine Zinc Oxide Zinc Cupric Oxide Copper Citric Acid Monohydrate Croscarmellose Sodium Crospovidone Anhydrous Dibasic Calcium Phosphate Gelatin Hypromelloses Magnesium Silicate Magnesium Stearate Cellulose, Microcrystalline Mineral Oil Povidone K30 Silicon Dioxide Sodium Ascorbate Sodium Benzoate Sodium Lauryl Sulfate Sorbic Acid Stearic Acid Sucrose Titanium Dioxide Triacetin ALPHA-TOCOPHEROL B;617"],"spl_unclassified_section":["NOTICE Contact with moisture can produce surface discoloration or erosion of the tablet.","Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487 Manufactured by: Contract Pharmacal Corp. Hauppauge, NY 11788 USA Iss. 08/09"],"storage_and_handling":["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. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product."],"version":"2","warnings":["Warning Keep this and all medications out of the reach of children. If pregnant, or planning to become pregnant or are currently breast-feeding, please contact your physician, or health-care provider before using or continuing use.","WARNING Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient."]}