Label: 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 capsule
Contains inactivated NDC Code(s)
NDC Code(s): 68220-086-05, 68220-086-25, 68220-086-30
- Packager: Alaven Pharmaceutical LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated March 8, 2010
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- SPL UNCLASSIFIED SECTION
PreferaOB ONE™ is a prescription prenatal/postnatal multivitamin/multimineral nutritional supplement with Omega-3 fatty acid (life'sDHA™1). 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:
- Proferrin® is a registered trademark of Colorado Biolabs, Inc , Cozad, NE.
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®* -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.
Gelatin, soybean oil, yellow beeswax, and lecithin.
- life'sDHA™ is a trademark of Martek Biosciences Corporation, Columbia, MD.
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.
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.
- BOXED WARNING (What is this?)
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.
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
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.
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 30 Softgels Blister Package
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 B6
- 1mg of folic acid
Plus Plant-based life'sDHA™ Omega-3
Supplement + DHA
INGREDIENTS AND APPEARANCE
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 capsule
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68220-086 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg Heme Iron Polypeptide (UNII: 31VDO12CJY) (Heme Iron Polypeptide - UNII:31VDO12CJY) Heme Iron Polypeptide 6 mg IRON DEXTRAN (UNII: 95HR524N2M) (IRON DEXTRAN - UNII:95HR524N2M) IRON DEXTRAN 22 mg Potassium Iodide (UNII: 1C4QK22F9J) (Potassium Cation - UNII:295O53K152) Potassium Iodide 175 ug Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 15 ug Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 25 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU] DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 200 mg .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL ACETATE, DL- - UNII:WR1WPI7EW8) .ALPHA.-TOCOPHEROL ACETATE, DL- 10 [iU] NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 17 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 50 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 30 ug CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (CALCIUM PANTOTHENATE - UNII:568ET80C3D) CALCIUM PANTOTHENATE 10 mg Inactive Ingredients Ingredient Name Strength HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C) 58 mg WAX, YELLOW (UNII: 2ZA36H0S2V) 34 mg GELATIN (UNII: 2G86QN327L) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 10 mg Product Characteristics Color PURPLE Score no score Shape CAPSULE Size 25mm Flavor Imprint Code AP;86 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68220-086-30 6 in 1 CARTON 1 NDC:68220-086-05 5 in 1 BLISTER PACK 2 NDC:68220-086-25 1 in 1 CARTON 2 NDC:68220-086-05 5 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 04/01/2010 Labeler - Alaven Pharmaceutical LLC (140210829) Establishment Name Address ID/FEI Business Operations International Vitamin Corporation 961594343 MANUFACTURE Establishment Name Address ID/FEI Business Operations Carton Services Inc 004215968 REPACK