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

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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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

PRINCIPAL DISPLAY PANEL - 30 Tablet Carton
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68220-083
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) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION6 mg
IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION28 mg
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION250 ug
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.5 ug
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM65 ug
CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION0.8 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.5 mg
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .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) PYRIDOXINE50 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN30 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION10 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (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)  
BRINOLASE (UNII: Z3GVO2327F)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SODIUM ASCORBATE (UNII: S033EH8359)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POLYETHYLENE GLYCOL, UNSPECIFIED (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;84
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68220-083-055 in 1 BLISTER PACK; Type 0: Not a Combination Product11/15/201001/01/2019
2NDC:68220-083-3030 in 1 CARTON; Type 0: Not a Combination Product11/15/201001/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other11/15/201001/01/2019
Labeler - Alaven Pharmaceutical LLC (140210829)

Revised: 1/2011
 
Alaven Pharmaceutical LLC