{"description":["DESCRIPTION Prenatal Plus Vitamin and Mineral Tablet is an orally administered prenatal / postnatal prescription dietary supplement for both lactating and non-lactating mothers and should be administered under the supervision of a licensed medical practitioner."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Before, during and/or after pregnancy, one tablet daily with a meal, or as directed by a licensed medical practitioner."],"effective_time":"20240108","how_supplied":["HOW SUPPLIED Prenatal Plus Vitamin and Mineral Tablets are beige colored tablets, debossed with \"677\" on one side, dispensed in bottles of 100 tablets (NDC 50268-677-01) Storage STORE AT CONTROLLED ROOM TEMPERATURE 15º to 30ºC (59º to 86ºF). Protect from light and moisture. Dispense in a tight, light-resistant container with child-resistant closure. Manufactured for: AvKARE Pulaski, TN 38478 Rev. 11/2021 AV Rev. 11/2021"],"id":"0e76f0d9-0ac2-e097-e063-6394a90adba2","indications_and_usage":["INDICATIONS AND USAGE To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL 100"],"precautions":["PRECAUTIONS High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as pernicious anemia), a condition that can cause nerve damage. Call your licensed medical practitioner about side effects. To report a serious adverse event or obtain product information, contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com"],"recent_major_changes":[""],"set_id":"da57de90-d103-71d2-e053-2a95a90afecc","spl_product_data_elements":["PRENATAL PLUS VITAMIN A ACETATE, .BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, FERROUS FUMARATE, ZINC OXIDE, CUPRIC OXIDE .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- ASCORBYL PALMITATE BUTYLATED HYDROXYTOLUENE CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE .ALPHA.-TOCOPHEROL, DL- FD&C RED NO. 40 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 GELATIN HYPROMELLOSES MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL SILICON DIOXIDE SODIUM ASCORBATE SODIUM BENZOATE SORBIC ACID STARCH, CORN STEARIC ACID SUCROSE SUNFLOWER OIL TITANIUM DIOXIDE TRIACETIN VITAMIN A ACETATE VITAMIN A BETA CAROTENE BETA CAROTENE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL THIAMINE MONONITRATE THIAMINE ION THIAMINE RIBOFLAVIN RIBOFLAVIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN CALCIUM CARBONATE CALCIUM CATION FERROUS FUMARATE FERROUS CATION ZINC OXIDE ZINC OXIDE CUPRIC OXIDE CUPRIC CATION Beige 677"],"storage_and_handling":["Storage STORE AT CONTROLLED ROOM TEMPERATURE 15º to 30ºC (59º to 86ºF). Protect from light and moisture. Dispense in a tight, light-resistant container with child-resistant closure. Manufactured for: AvKARE Pulaski, TN 38478 Rev. 11/2021 AV Rev. 11/2021"],"version":"3","warnings":["WARNINGS WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately."],"warnings_table":["<table><col/><tbody><tr><td styleCode=\"     Botrule          Toprule         Lrule          Rrule     \"><content styleCode=\"bold\">WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.</content><content styleCode=\"bold\"> </content></td></tr></tbody></table>"]}