{"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 This product is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION Each Vinate ® Care Chewable Tablet Contains: Vitamin C ( Vitamin C is provided as a blend of Calcium Ascorbate and Calcium Threonate. Ascorbic Acid and Threonic Acid) .........................................50 mg Vitamin D 3 (Cholecalciferol).......................................................................6 mcg Vitamin E (as dl-Alpha Tocopheryl Acetate)............................................. 3.5 IU Vitamin B 6 (as Pyridoxine HCl)....................................................................2 mg Folic Acid, USP..........................................................................................1 mg Calcium (as Calcium Carbonate) .............................................................250 mg Iron (as Ferrous Fumarate)........................................................................40 mg Magnesium (as Magnesium Oxide, USP) ..................................................50 mg Zinc (as Zinc Oxide, USP) .......................................................................15 mg Copper (as Cupric Oxide) .........................................................................2 mg Inactive Ingredients: Acacia, Carrageenan, Croscarmellose Sodium, Crospovidone, This product contains FD&C Yellow No. 6 Lake as a color additive FD&C Yellow No. 6 Lake, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Orange Flavor, Polyvinylpyrrolidone, Silica, Starch, Stearic Acid, Sugar, Tartaric Acid, Unsaturated Mono & Diglycerides and Xylitol."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual dosage is one tablet daily, or as prescribed by a physician. Do not exceed recommended dosage."],"effective_time":"20110107","general_precautions":["General Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. 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."],"geriatric_use":["Geriatric Use No clinical studies have been performed in patients age 65 and over to determine whether older persons respond differently from younger persons. Dosage should always begin at the low end of the dosage scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function and/or concomitant diseases, or other drug therapy."],"how_supplied":["HOW SUPPLIED Vinate ® Care Chewable tablets are available as orange, round concave-shaped tablets, debossed B 576. Supplied in bottles of 30 tablets, NDC 51991-576-33. 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. 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":"9b01f90c-dd89-4343-a4c7-e830304d5b56","indications_and_usage":["INDICATIONS AND USAGE Vinate ® Care Chewable tablets are indicated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period - for both lactating and non-lactating mothers. They are also useful for supplementing the nutritional status prior to conception."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Breckenridge Pharmaceutical, Inc. NDC 51991-576-33 Vinate ® Care Chewables Prenatal Vitamin and Mineral Supplement Rx Only 30 Tablets Principal Display Panel"],"pediatric_use":["Pediatric Use Safety and effectiveness in the pediatric population, under 12, have not been established."],"precautions":["PRECAUTIONS General Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. 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. Pediatric Use Safety and effectiveness in the pediatric population, under 12, have not been established. Geriatric Use No clinical studies have been performed in patients age 65 and over to determine whether older persons respond differently from younger persons. Dosage should always begin at the low end of the dosage scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function and/or concomitant diseases, or other drug therapy."],"set_id":"ad7ddef8-1eb4-4521-9b45-d7273e82b2ce","spl_product_data_elements":["Vinate Care Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol acetate, dl-, Pyridoxine Hydrochloride, Folic Acid, Calcium Carbonate, Ferrous Fumurate, Magnesium Oxide, Zinc Oxide and Cupric Oxide Ascorbic Acid Ascorbic Acid Cholecalciferol Cholecalciferol .alpha.-tocopherol acetate, dl- .alpha.-tocopherol acetate, dl- Pyridoxine Hydrochloride Pyridoxine Folic Acid Folic Acid Calcium Carbonate Calcium Ferrous Fumarate Iron Magnesium Oxide MAGNESIUM CATION Zinc Oxide Zinc Cupric Oxide Copper Acacia Carrageenan Croscarmellose Sodium Crospovidone FD&C Yellow no. 6 Aluminum Oxide Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Povidone K30 Silicon Dioxide Stearic Acid Raw Sugar Tartaric Acid Xylitol speckled B576"],"spl_unclassified_section":["Prenatal Vitamin and Mineral Supplement Rx Only","Manufactured by: Contract Pharmacal Corp. Hauppauge, NY 11788 USA Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487 Rx Only Rev. 06/09"],"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":["WARNINGS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient."]}