PREFERA OB PLUS DHA- folic acid, heme iron polypeptide, iron dextran, potassium iodide, zinc oxide, selenium, cupric sulfate, cholecalciferol, thiamine mononitrate, alpha-tocopherol succinate, d-, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, and calcium pantothenate tablet 
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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Prefera OB®
+ DHA
The Prenatal YOU CAN COUNT ON!

Prenatal/Postnatal Multivitamin/Multimineral
PreferaOB® Tablets & life'sDHA1 Softgels

Rx Only


1
life'sDHA™ is a trademark of Martek Biosciences Corporation, Columbia, MD.

DESCRIPTION

PreferaOB® + DHA is a prescription prenatal/postnatal multivitamin/multimineral (PreferaOB®) and Omega-3 fatty acid (life'sDHA™) nutritional supplement. PreferaOB® + DHA is a small, oval, film-coated, purple tablet with black core, debossed and bisected with "AP/88" on one side, and plain on the other (PreferaOB®) and a clear essential fatty acid softgel containing an amber to light/dark orange semi-solid mixture (life'sDHA™).

Each PreferaOB® tablet contains:

VITAMINSMINERALS
*
Proferrin® is a registered trademark of Colorado Biolabs, Inc., Cozad, NE.
D3 (as cholecalciferol)400 IUIron
E (as d-alpha tocopheryl succinate)10 IU  as PIC (polysaccharide iron complex)22 mg
B1 (as thiamin mononitrate)1.5 mg  as HIP (heme iron polypeptide as Proferrin®*
B2 (as riboflavin)1.6 mg  bovine source, USDA certified)6 mg
B3 (niacin as niacinamide)17 mgIodine (as potassium iodide)175 mcg
B6 (as pyridoxine HCl)50 mgZinc (as zinc oxide)15 mg
Folic Acid1 mgSelenium (as sodium selenate)65 mcg
B12 (as cyanocobalamin)12 mcgCopper (as cupric sulfate)0.8 mg
Biotin30 mcg
B5 (as d-calcium pantothenate)10 mg

INACTIVE INGREDIENTS

Microcrystalline cellulose, croscarmellose sodium, crospovidone, magnesium stearate, silicon dioxide, dextran, dicalcium phosphate, sucrose, protease, modified food starch, dl-alpha tocopherol, sodium ascorbate, ethylcellulose, resin, coating (polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, D&C red no. 30 aluminum lake, FD&C blue no. 2 aluminum lake).

Each life'sDHA™ Softgel contains:   Docosahexaenoic Acid (DHA)                      200 mg
DHA is derived from the oils of microalgae. Inactive ingredients in the DHA softgel include: gelatin, glycerin USP, water.

INDICATIONS AND USAGE

PreferaOB® + DHA is a prescription multivitamin/multimineral (PreferaOB®) and Omega-3 fatty acid (life'sDHA™) nutritional supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. PreferaOB® + DHA 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 0.1mg 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 tablet and one softgel daily with or without food, or as prescribed by a licensed health care provider with prescribing authority.

HOW SUPPLIED

PreferaOB® + DHA is supplied in child-resistant blister packs of 30 tablets and 30 softgels (NDC 68220-089-30) and as a Professional Sample (NDC 68220-089-25).

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]

Dispense in a tight, light-resistant container to protect from light and moisture.

For medical inquiries call toll free 1-888-317-0001

www.PreferaOB.com

Manufactured for:
Alaven® Pharmaceutical LLC, Marietta, GA 30062

Patents Pending

PreferaOB® is a registered trademark of Alaven® Pharmaceutical LLC, Marietta, GA.

089-0709-01
Ref CL-089-0709-01

PRINCIPAL DISPLAY PANEL - 30 Tablets + 30 Softgels Carton

Rx Only

NDC 68220-089-30
30 Tablets + 30 Softgels

PreferaOB®
+ DHA

The Prenatel YOU CAN COUNT ON!

ONLY prenatal with Natural, Body-Ready HEME Iron + DHA

15 Essential Vitamins and Minerals including:

Plant-based life'sDHA™ Omega-3
High dose of vitamin B6
1mg of folic acid

ACTUAL
SIZE

Pre/Post-natal Nutritional
Supplement + DHA

www.PreferaOB.com

PRINCIPAL DISPLAY PANEL - 30 Tablets + 30 Softgels Carton
PREFERA OB PLUS DHA 
folic acid, heme iron polypeptide, iron dextran, potassium iodide, zinc oxide, selenium, cupric sulfate, cholecalciferol, thiamine mononitrate, alpha-tocopherol succinate, d-, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, biotin, and calcium pantothenate tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68220-089
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) (Iodine - UNII:9679TC07X4) Potassium Iodide175 ug
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc - UNII:J41CSQ7QDS) Zinc Oxide15 mg
Selenium (UNII: H6241UJ22B) (Selenium - UNII:H6241UJ22B) Selenium65 ug
CUPRIC SULFATE (UNII: LRX7AJ16DT) (COPPER - UNII:789U1901C5) CUPRIC SULFATE0.8 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE - UNII:X66NSO3N35) THIAMINE MONONITRATE1.5 mg
ALPHA-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (ALPHA-TOCOPHEROL SUCCINATE, D- - UNII:LU4B53JYVE) ALPHA-TOCOPHEROL SUCCINATE, D-10 [iU]
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.6 mg
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
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 66 mg
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 51.5 mg
MAGNESIUM STEARATE (UNII: 70097M6I30) 5 mg
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 5 mg
DEXTRAN 1 (UNII: I8LHQ0D645)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
SUCROSE (UNII: C151H8M554)  
ASPERGILLUS FLAVUS VAR. ORYZAE PROTEASE (UNII: Z3GVO2327F)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM ASCORBATE (UNII: S033EH8359)  
ETHYLCELLULOSE (UNII: 7Z8S9VYZ4B)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
Product Characteristics
ColorPURPLEScore2 pieces
ShapeOVALSize15mm
FlavorImprint Code AP;88
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68220-089-055 in 1 BLISTER PACK
2NDC:68220-089-3030 in 1 CARTON
3NDC:68220-089-055 in 1 BLISTER PACK
4NDC:68220-089-255 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER04/01/2009
Labeler - Alaven Pharmaceutical LLC (140210829)
Establishment
NameAddressID/FEIBusiness Operations
Nexgen Pharma Inc.160356114MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Carton Services Inc004215968REPACK

Revised: 2/2010
Document Id: c697dfae-210c-43a6-b893-f3054e74901c
Set id: 0539ec9c-b625-4c4e-a321-e7073041c8e0
Version: 1
Effective Time: 20100216
 
Alaven Pharmaceutical LLC