{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8410 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ."],"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 ™* ). 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: VITAMINS MINERALS C (as ascorbic acid)……………………..25 mg D 3 (as cholecalciferol) ............................ 400 IU E (as dl -alpha tocopheryl acetate).……… 10 IU B 3 (niacin as niacinamide) .........................17 mg B 6 (as pyridoxine HCl)..............................50 mg Folic Acid ..................................................1 mg B 12 (as cyanocobalamin) .......................12 mcg Biotin ....................................................30 mcg B 5 (as d-calcium pantothenate).................10 mg Iron………………………….28 mg (as PIC - polysaccharide iron complex) (as HIP - heme iron polypeptide as Proferrin ®** ) Iodine (as potassium iodide)175 mcg Zinc (as zinc oxide) ................ 15 mg OMEGA-3 FATTY ACID Docosahexaenoic Acid (DHA)…………200 mg 200 mg of DHA from 500 mg of algal oil derived from Crypthecodinium cohnii. life’sDHA ™ Oil includes: DHA algal oil, high oleic sunflower oil, ascorbyl palmitate (vitamin A) & tocopherols (as antioxidants). 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."],"description_table":["C (as ascorbic acid)……………………..25 mg D 3 (as cholecalciferol) ............................ 400 IU E (as dl -alpha tocopheryl acetate).……… 10 IU B 3 (niacin as niacinamide) .........................17 mg B 6 (as pyridoxine HCl)..............................50 mg Folic Acid ..................................................1 mg B 12 (as cyanocobalamin) .......................12 mcg Biotin ....................................................30 mcg B 5 (as d-calcium pantothenate).................10 mg Iron………………………….28 mg (as PIC - polysaccharide iron complex) (as HIP - heme iron polypeptide as Proferrin ®** ) Iodine (as potassium iodide)175 mcg Zinc (as zinc oxide) ................ 15 mg
VITAMINS MINERALS
"],"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":"20151021","how_supplied":["HOW SUPPLIED: PreferaOB ONE ® is supplied in child-resistant blister packs of 30 softgels (NDC 0037-0086-30). KEEP OUT OF REACH OF CHILDREN."],"id":"8e6a0d05-cc2c-413d-aca9-41373ecaec28","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 CARTON Rx Only NDC 0037-0086-30 PreferaOB ONE ® Pre/Post-natal Nutritional Supplement + DHA HEME Iron Non-HEME Iron 50 mg Vitamin B 6 1 mg Folic Acid life'sDHA ™ 30 Softgels PreferaOB ONE 30-ct Carton Label"],"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":"95f371f9-51cc-474c-90b8-b1ac479cbc3b","spl_product_data_elements":["PreferaOB ONE ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, d-, iron sucrose, heme iron polypeptide, potassium iodide, zinc oxide, schizochytrium dha oil ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL ACETATE, DL- .ALPHA.-TOCOPHEROL, DL- NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN BIOTIN BIOTIN CALCIUM PANTOTHENATE CALCIUM CATION IRON SUCROSE FERRIC CATION HEME IRON POLYPEPTIDE FERROUS CATION POTASSIUM IODIDE IODIDE ION ZINC OXIDE ZINC OXIDE SCHIZOCHYTRIUM DHA OIL DOCONEXENT SUNFLOWER OIL ASCORBYL PALMITATE TOCOPHEROL GELATIN SOYBEAN OIL YELLOW WAX LECITHIN, SOYBEAN D&C RED NO. 33 FD&C BLUE NO. 1 TITANIUM DIOXIDE WATER AP;86"],"spl_unclassified_section":["Prenatal/Postnatal Multivitamin/Multimineral/ DHA softgel Rx Only","Other Ingredients: Gelatin, soybean oil, yellow beeswax, lecithin, D&C red #33, FD&C blue #1, titanium dioxide and purified water."],"storage_and_handling":["STORAGE: Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). To protect from light, dispense in carton provided. Once open, blisters should be stored in carton. Distributed by: Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120 U.S. Patent Nos. 7,585,527 and 8,080,520. * life’sDHA ™ is a trademark of Martek Biosciences Corporation, Columbia, MD. ** Proferrin ® is a registered trademark of Colorado BioLabs, Inc., Cozad, NE. © 2015 Meda Pharmaceuticals Inc. IN-6886-05 Rev 7/2015"],"version":"3","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."]}