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 
Alaven Pharmaceutical LLC

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.

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PreferaOB ONE

Prenatal/Postnatal Multivitamin/
Multimineral/DHA softgel

Rx Only

DESCRIPTION

PreferaOB ONE is a prescription prenatal/postnatal multivitamin/multimineral nutritional supplement with Omega-3 fatty acid (life'sDHA1). 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 Acid1 mg
Vitamin B12 (as cyanocobalamin)12 mcg
Biotin30 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.

Inactive Ingredients

Gelatin, soybean oil, yellow beeswax, and lecithin.


1
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.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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.

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.

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.

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION

One softgel daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.

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

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

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 B6

- 1mg of folic acid

Plus Plant-based life'sDHA™ Omega-3

Pre/Post-natal Nutritional

Supplement + DHA

life'sDHA™

www.PreferaOB.com

Chemical Structure
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
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68220-086
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
Heme Iron Polypeptide (UNII: 31VDO12CJY) (Heme Iron Polypeptide - UNII:31VDO12CJY) Heme Iron Polypeptide6 mg
IRON DEXTRAN (UNII: 95HR524N2M) (IRON DEXTRAN - UNII:95HR524N2M) IRON DEXTRAN22 mg
Potassium Iodide (UNII: 1C4QK22F9J) (Potassium Cation - UNII:295O53K152) Potassium Iodide175 ug
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide15 ug
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid25 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT200 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) NIACINAMIDE17 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE50 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN30 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (CALCIUM PANTOTHENATE - UNII:568ET80C3D) CALCIUM PANTOTHENATE10 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C) 58 mg
WAX, YELLOW (UNII: 2ZA36H0S2V) 34 mg
GELATIN (UNII: 2G86QN327L)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 10 mg
Product Characteristics
ColorPURPLEScoreno score
ShapeCAPSULESize25mm
FlavorImprint Code AP;86
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68220-086-306 in 1 CARTON
1NDC:68220-086-055 in 1 BLISTER PACK
2NDC:68220-086-251 in 1 CARTON
2NDC:68220-086-055 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other04/01/2010
Labeler - Alaven Pharmaceutical LLC (140210829)
Establishment
NameAddressID/FEIBusiness Operations
International Vitamin Corporation961594343MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Carton Services Inc004215968REPACK

Revised: 3/2010
Document Id: 69e082a6-77dd-46e0-b3eb-90bb6d167b82
Set id: db9fede8-b6d5-40a9-84cb-f928553f8e6c
Version: 1
Effective Time: 20100308
 
Alaven Pharmaceutical LLC