PreferaOB

Generic Name: multivitamin, multimineral tablet
Dosage Form: tablet

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.

PreferaOB®
Prenatal/Postnatal Multivitamin/
Multimineral Tablets

Rx Only

PreferaOB Description

PreferaOB® is a prescription prenatal/postnatal multivitamin/multimineral nutritional supplement. PreferaOB® 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.

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, 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).

Indications and Usage for PreferaOB

PreferaOB® is a prescription multivitamin/multimineral 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® 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

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.

PreferaOB Dosage and Administration

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

How is PreferaOB Supplied

PreferaOB® is supplied in a child-resistant bottle of 90 tablets (NDC 68220-084-90) and as a Professional Sample (NDC 68220-084-25).

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.

U.S. Patent No. 7,585,527

*Proferrin® is a registered trademark of Colorado Biolabs, Inc., Cozad, NE.
PreferaOB® is a registered trademark of Alaven Pharmaceutical LLC,
Marietta, GA 30062

6-084-90-03-0710CR
CL6-084-00-01-0710a

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

NDC 68220-084-90
90 Tablets

PreferaOB®

www.PreferaOB.com

Manufactured for:
ALAVEN®
PHARMACEUTICAL LLC
Marietta, GA 30062

Rx Only

PreferaOB 
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 LABEL Item Code (Source) NDC:68220-084
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 (POTASSIUM CATION) Potassium Iodide 250 ug
Zinc Oxide (Zinc Oxide) Zinc Oxide 4.5 ug
Selenium (Selenium) Selenium 65 ug
CUPRIC SULFATE (CUPRIC CATION) 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
CROSPOVIDONE 26 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  
ETHYLCELLULOSE  
POLYVINYL ALCOHOL  
POLYETHYLENE GLYCOL  
TALC  
TITANIUM DIOXIDE  
D&C RED NO. 30  
FD&C BLUE NO. 2  
ALUMINUM OXIDE  
Product Characteristics
Color PURPLE Score 2 pieces
Shape OVAL Size 15mm
Flavor Imprint Code AP;84
Contains         
Packaging
# Item Code Package Description
1 NDC:68220-084-90 90 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/27/2010
Labeler - Alaven Pharmaceutical LLC (140210829)
Establishment
Name Address ID/FEI Operations
Nexgen Pharma Inc. 160356114 MANUFACTURE
Revised: 09/2010
 
Alaven Pharmaceutical LLC
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