{"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 PreferaOB ONE ™ is a prescription prenatal/postnatal multivitamin/multimineral nutritional supplement with Omega-3 fatty acid ( life'sDHA ™ life'sDHA ™ is a trademark of Martek Biosciences Corporation, Columbia, MD. ). PreferaOB ONE ™ is an oblong shaped, opaque purple colored softgel, imprinted \"AP 86\" in white ink on one side and plain on the other. Each PreferaOB ONE ™ Softgel contains: Vitamin C (as ascorbic acid) 25 mg Vitamin D3 (as cholecalciferol) 400 IU Vitamin E (as dl-alpha tocopheryl acetate) 10 IU Vitamin B3 (niacin as niacinamide) 17 mg Vitamin B6 (as pyridoxine HCl) 50 mg Folic Acid 1 mg Vitamin B12 (as cyanocobalamin) 12 mcg Biotin 30 mcg Vitamin B5 (as d-calcium pantothenate) 10 mg Iron as PIC (polysaccharide iron complex) 22 mg as HIP (heme iron polypeptide as Proferrin ® Proferrin ® is a registered trademark of Colorado Biolabs, Inc , Cozad, NE. -bovine source, USDA certified) 6 mg Iodine (as potassium iodide) 175 mcg Zinc (as zinc oxide) 15 mg Docosahexaenoic Acid (DHA) 200 mg DHA is derived from the oils of microalgae, which is grown outside of the ocean, in a controlled environment, eliminating the risk of oceanic contamination. Inactive Ingredients Gelatin, soybean oil, yellow beeswax, and lecithin."],"description_table":["<table width=\"50%\"> <col width=\"40%\" align=\"left\"/> <col width=\"10%\" align=\"right\"/> <tbody> <tr styleCode=\"toprule\"> <td>Vitamin C (as ascorbic acid)</td> <td>25 mg</td> </tr> <tr> <td>Vitamin D3 (as cholecalciferol)</td> <td>400 IU</td> </tr> <tr> <td>Vitamin E (as dl-alpha tocopheryl acetate)</td> <td>10 IU</td> </tr> <tr> <td>Vitamin B3 (niacin as niacinamide)</td> <td>17 mg</td> </tr> <tr> <td>Vitamin B6 (as pyridoxine HCl)</td> <td>50 mg</td> </tr> <tr> <td>Folic Acid</td> <td>1 mg</td> </tr> <tr> <td>Vitamin B12 (as cyanocobalamin)</td> <td>12 mcg</td> </tr> <tr> <td>Biotin</td> <td>30 mcg</td> </tr> <tr> <td>Vitamin B5 (as d-calcium pantothenate)</td> <td>10 mg</td> </tr> <tr> <td>Iron</td> <td/> </tr> <tr> <td> as PIC (polysaccharide iron complex)</td> <td>22 mg</td> </tr> <tr> <td> as HIP (heme iron polypeptide as </td> <td/> </tr> <tr> <td> Proferrin<sup>&#xAE;</sup> <footnote>Proferrin<sup>&#xAE;</sup> is a registered trademark of Colorado Biolabs, Inc , Cozad, NE.</footnote> -bovine source, USDA certified)</td> <td>6 mg</td> </tr> <tr> <td>Iodine (as potassium iodide)</td> <td>175 mcg</td> </tr> <tr> <td>Zinc (as zinc oxide)</td> <td>15 mg</td> </tr> <tr> <td> </td> <td> </td> </tr> <tr styleCode=\"botrule\"> <td>Docosahexaenoic Acid (DHA)</td> <td>200 mg</td> </tr> </tbody> </table>"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One softgel daily with or without food, or as prescribed by a licensed health care provider with prescribing authority."],"effective_time":"20100308","how_supplied":["HOW SUPPLIED PreferaOB ONE ™ is supplied in child-resistant blister packs of 30 softgels (NDC 68220-086-30) and as a Professional Sample (NDC 68220-086-25). KEEP OUT OF REACH OF CHILDREN. STORAGE Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). [See current USP] To protect from light, dispense in carton provided. Once open, blisters should be stored in carton. For medical inquiries call toll free 1-888-317-0001 www.PreferaOB.com"],"id":"69e082a6-77dd-46e0-b3eb-90bb6d167b82","indications_and_usage":["INDICATIONS AND USAGE PreferaOB ONE ™ is a prescription multivitamin/multimineral nutritional supplement with Omega-3 fatty acid ( life'sDHA™ ) indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. PreferaOB ONE ™ is also beneficial in improving the nutritional status of women prior to conception."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 30 Softgels Blister Package Rx Only NDC 68220-086-30 30 Softgels PreferaOB ONE ™ The Prenatal YOU CAN COUNT ON! FIRST and ONLY prenatal with Natural, Body-Ready HEME Iron + DHA In an all-in-one softgel 12 Essential Vitamins and Minerals including: - High dose of vitamin B 6 - 1mg of folic acid Plus Plant-based life'sDHA™ Omega-3 Pre/Post-natal Nutritional Supplement + DHA life's DHA™ www.PreferaOB.com Chemical Structure"],"precautions":["PRECAUTIONS Folic acid when administered as a single agent in doses above 0.1 mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. Pregnant women and nursing mothers should avoid supplemental doses of vitamin E higher than RDA amounts. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered."],"set_id":"db9fede8-b6d5-40a9-84cb-f928553f8e6c","spl_product_data_elements":["PreferaOB One folic acid, heme iron polypeptide, iron dextran, potassium iodide, zinc oxide, ascorbic acid, cholecalciferol, doconexent, .alpha.-tocopherol acetate, dl-, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin and calcium pantothenate capsule FOLIC ACID FOLIC ACID Heme Iron Polypeptide Heme Iron Polypeptide IRON DEXTRAN IRON DEXTRAN Potassium Iodide Potassium Cation Zinc Oxide Zinc Oxide Ascorbic Acid Ascorbic Acid CHOLECALCIFEROL CHOLECALCIFEROL DOCONEXENT DOCONEXENT .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL ACETATE, DL- NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE CYANOCOBALAMIN CYANOCOBALAMIN BIOTIN BIOTIN CALCIUM PANTOTHENATE CALCIUM PANTOTHENATE HYDROGENATED SOYBEAN OIL WAX, YELLOW GELATIN LECITHIN, SOYBEAN AP;86"],"spl_unclassified_section":["Prenatal/Postnatal Multivitamin/ Multimineral/DHA softgel Rx Only","Manufactured for: Alaven ® Pharmaceutical LLC Marietta, GA 30062 U.S. Patent No. 7,585,527 PreferaOB ® is a registered trademark and PreferaOB ONE ™ is a trademark of Alaven ® Pharmaceutical LLC, Marietta, GA. CL6-086-00-01-1209a"],"storage_and_handling":["STORAGE Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). [See current USP] To protect from light, dispense in carton provided. Once open, blisters should be stored in carton. For medical inquiries call toll free 1-888-317-0001 www.PreferaOB.com"],"version":"1","warnings":["WARNING Ingestion of more than 3 grams of Omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of Omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding diathesis."]}