PREFERAOB 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

———-

Prenatal/Postnatal Multivitamin/
Multimineral PreferaOB® Tablets &
life’sDHA™* Softgels

Rx Only

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/84” 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:
VITAMINS
D3 (as cholecalciferol) 400 IU
E (as d-alpha tocopheryl succinate) 10 IU
B1 (as thiamin mononitrate) 1.5 mg
B2 (as riboflavin) 1.6 mg
B3 (niacin as niacinamide) 17 mg
B6 (as pyridoxine HCl) 50 mg
Folic Acid 1 mg
B12 (as cyanocobalamin) 12 mcg
Biotin 30 mcg
B5 (as d-calcium pantothenate) 10 mg
MINERALS
Iron
  as Polysaccharide Iron Complex (a complex of iron, glucose,   maltose, and dextrin; Iron Content ~ 46%) yielding 28 mg
  as HIP (heme iron polypeptide as Proferrin®** –
  bovine source, USDA certified) yielding
6 mg
Iodine (as potassium iodide) 250 mcg
Zinc (as zinc oxide) 4.5 mg
Selenium (as sodium selenate) 65 mcg
Copper (as cupric sulfate) 0.8 mg

INACTIVE INGREDIENTS:

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

Each life’sDHA™ Softgel contains:
Total omega-3 long chain fatty acids 203 mg
  as Docosahexaenoic Acid (DHA) 200 mg
  as α-linolenic acid (ALA) 0.5 mg
  as Docosapentaenoic acid (DPA) 2.5 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. Ingredients include: DHA Algal Oil, High Oleic Sunflower Oil, Ascorbyl Palmitate & Tocopherols (as antioxidants) in a Gelatin Capsule (Gelatin, Glycerin, Water, and Caramel, Carmine, Calcium Carbonate and Turmeric as coloring).

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 non-lactating 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 68220-083-30) and as a Professional Sample (NDC 68220-083-25).

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

life’sDHA
HEALTHY BRAIN, EYES, HEART

Manufactured for:
ALAVEN®
PHARMACEUTICAL LLC

Alaven® Pharmaceutical LLC, Marietta, GA 30062

U.S. Patent No. 7,585,527
*life’sDHA™ is a trademark of Martek Biosciences Corporation, Columbia, MD.
**Proferrin® is a registered trademark of Colorado Biolabs, Inc., Cozad, NE.
PreferaOB® is a registered trademark and PreferaOB + DHA™ is a
trademark of Alaven® Pharmaceutical LLC, Marietta, GA.

6-083-30-06-0710CR

Ref CL6-083-00-01-0710b

PRINCIPAL DISPLAY PANEL – 30 Tablet Carton

Rx Only

NDC 68220-083-30
30 Tablets + 30 Softgels

PreferaOB
+DHA

life’sDHA
HEALTHY BRAIN, EYES, HEART

ONLY prenatal with Natural,
Body-Ready HEME Iron + DHA
15 Essential Vitamins and
Minerals including:

50mg of vitamin B6
1mg of folic acid

Plus Plant-based life’sDHA™ Omega-3

Pre/Post-natal Nutritional
Supplement + DHA

www.PreferaOB.com


PREFERAOB 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 Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68220-083
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
Heme Iron Polypeptide (Heme Iron Polypeptide) Heme Iron Polypeptide 6 mg
IRON DEXTRAN (IRON DEXTRAN) IRON DEXTRAN 28 mg
Potassium Iodide (Iodine) Potassium Iodide 250 ug
Zinc Oxide (Zinc) Zinc Oxide 4.5 ug
Selenium (Selenium) Selenium 65 ug
CUPRIC SULFATE (COPPER) CUPRIC SULFATE 0.8 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 1.5 mg
ALPHA-TOCOPHEROL SUCCINATE, D- (ALPHA-TOCOPHEROL SUCCINATE, D-) ALPHA-TOCOPHEROL SUCCINATE, D- 10 [iU]
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.6 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 17 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 50 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
BIOTIN (BIOTIN) BIOTIN 30 ug
CALCIUM PANTOTHENATE (CALCIUM PANTOTHENATE) CALCIUM PANTOTHENATE 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE 66 mg
CROSCARMELLOSE SODIUM 51.5 mg
MAGNESIUM STEARATE 5 mg
SILICON DIOXIDE 5 mg
DEXTRAN 1  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
SUCROSE  
ASPERGILLUS FLAVUS VAR. ORYZAE PROTEASE  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)  
.ALPHA.-TOCOPHEROL ACETATE, DL-  
SODIUM ASCORBATE  
ETHYLCELLULOSES  
POLYVINYL ALCOHOL  
POLYETHYLENE GLYCOL  
TALC  
TITANIUM DIOXIDE  
D&C RED NO. 30  
FD&C BLUE NO. 2  
Product Characteristics
Color PURPLE Score 2 pieces
Shape OVAL Size 15mm
Flavor Imprint Code AP;84
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 68220-083-05 5 TABLET In 1 BLISTER PACK None
2 68220-083-30 30 TABLET In 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/15/2010

Labeler – Alaven Pharmaceutical LLC (140210829)
Establishment
Name Address ID/FEI Operations
Nexgen Pharma Inc. 160356114 MANUFACTURE
Establishment
Name Address ID/FEI Operations
Carton Services Inc 004215968 REPACK
Revised: 01/2011Alaven Pharmaceutical LLC