{"adverse_reactions":["ADVERSE REACTIONS In some cases, allergic hypersensitivity has been reported following administration of folic acid. Mild gastrointestinal disturbances may occur with products containing ferrous fumarate (iron), but usually subside with continuation of therapy."],"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 the reach of children. In case of accidental overdose, call a doctor or poison control center immediately."],"description":["Each PNV tablet contains: VITAMINS: Vitamin A (as acetate) 2500 IU Vitamin C (as Ascorbic Acid) 60 mg Vitamin D3 (as Cholecalciferol) 400 IU Vitamin E (as Tocopheryl acetate) 15 IU Vitamin B1 (as Thiamine Mononitrate) 1.05 mg Vitamin B2 (as Riboflavin, USP) 1.2 mg Niacin (as Niacinamide) 13.5 mg Vitamin B6 (as Pyridoxine HCL) 1.05 mg Folic Acid 1 mg Vitamin B12 (as Cyanocobalamin) 4.5 mcg MINERAL: Iron (as ferrous fumarate) 27 mg Calcium (as Dibasic Calcium Phosphate) 50 mg OTHER INGREDIENTS Microcrystalline Cellulose, Croscarmellose Sodium, Citric Acid, Talc and Magnesium Stearate."],"description_table":["
VITAMINS:
Vitamin A (as acetate) 2500 IU
Vitamin C (as Ascorbic Acid) 60 mg
Vitamin D3 (as Cholecalciferol) 400 IU
Vitamin E (as Tocopheryl acetate) 15 IU
Vitamin B1 (as Thiamine Mononitrate) 1.05 mg
Vitamin B2 (as Riboflavin, USP) 1.2 mg
Niacin (as Niacinamide) 13.5 mg
Vitamin B6 (as Pyridoxine HCL) 1.05 mg
Folic Acid 1 mg
Vitamin B12 (as Cyanocobalamin) 4.5 mcg
MINERAL:
Iron (as ferrous fumarate) 27 mg
Calcium (as Dibasic Calcium Phosphate) 50 mg
"],"dosage_and_administration":["DIRECTIONS One tablet daily with a meal, or as directed by a physician."],"effective_time":"20121214","how_supplied":["STORE AT CONTROLLED ROOM TEMPERATURE 15°-30°C (59°-86°F). PROTECT FROM EXCESS HEAT AND MOISTURE. Dispense in a tight, light-resistant container with child-resistant closure."],"id":"f3af7e93-287a-4e40-9934-daf64e15efde","openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 400 Tablet Bottle Label 44946-1046-4 Rx only PNV Prenatal Health PNV Prenatal Vitamins FOLIC ACID + IRON MULTIVITAMIN PLUS VITAMIN A Tablets Provides vitamin and mineral supplementation throughout pregnancy and postnatal period Sugar & Gluten Free SCI Sancilio & Company, Inc Developing good science into great medicine 400 TABLETS PRINCIPAL DISPLAY PANEL - 400 Tablet Bottle Label"],"precautions":["CAUTION Folic acid may partially correct the hematological damage due to vitamin B12 deficiency of pernicious anemia, while the associated neurological damage progresses."],"set_id":"97b99e3f-0bc6-46a5-956d-9141d22f3d87","spl_product_data_elements":["PNV Prenatal Vitamin Plus Vitamin A .Alpha.-Tocopherol Acetate, DL-, Ascorbic Acid, Cholecalciferol, Cyanocobalamin, Folic Acid, Ferrous fumarate, Calcium Phosphate, Dibasic, Anhydrous, Niacinamide, Pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate, and Vitamin A Acetate .Alpha.-Tocopherol Acetate, DL- .Alpha.-Tocopherol, DL- Ascorbic Acid Ascorbic Acid Cholecalciferol Cholecalciferol Cyanocobalamin Cyanocobalamin Folic Acid Folic Acid Ferrous fumarate Ferrous cation Calcium Phosphate, Dibasic, Anhydrous CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS Niacinamide Niacinamide Pyridoxine Hydrochloride Pyridoxine Riboflavin Riboflavin Thiamine Mononitrate Thiamine Ion Thiamine Vitamin A Acetate VITAMIN A Cellulose, Microcrystalline Croscarmellose sodium Anhydrous Citric Acid Talc Magnesium stearate Light brown to brown-speckled capsule-shaped"],"spl_unclassified_section":["PNV tablets are formulated to provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period, for both lactating and non-lactating mothers, and is useful for improving nutritional status prior to conception.","This medical food product is formulated to be administered orally, under the supervision of a physician and is intended for the management of a dietary deficiency of folic acid and iron for which a distinctive nutritional requirement, based on recognized scientific principles, has been established by medical evaluation. The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health insurance and state level reimbursement programs and is not intended to denote registration or approval from the FDA. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. DO NOT USE IF INNER SAFETY SEAL IS BROKEN OR MISSING. Manufactured by: Sancilio & Company, Inc. , Riviera Beach, FL 33404 (800) SCI-8711 © 2011 Sancilio & Company, Inc. REV: 12/07/12"],"storage_and_handling":["STORE AT CONTROLLED ROOM TEMPERATURE 15°-30°C (59°-86°F). PROTECT FROM EXCESS HEAT AND MOISTURE. Dispense in a tight, light-resistant container with child-resistant closure."],"version":"1"}