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PreferaOB

Pronunciation

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

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 MINERALS
D3 (as cholecalciferol) .........................400 IU
E (as d-alpha tocopheryl acid succinate) 10 IU
B1 (as thiamine 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
Iron
  as Polysaccharide Iron
  Complex............................... 28 mg
  as HIP (heme iron polypeptide as
  Proferrin® - bovine source,
  USDA certified) ..................... 6 mg
Iodine (as potassium iodide)   250mcg
Zinc (as zinc oxide) ................ 4.5 mg
Selenium (as sodium selenate) 65 mcg
Copper (as cupric sulfate)....... 0.8 mg

Other Ingredients:

Microcrystalline cellulose, croscarmellose sodium, crospovidone, silicon dioxide, magnesium stearate (vegetable source), modified food starch, dibasic calcium phosphate, resin, sucrose, ethylcellulose, sodium ascorbate, medium chain triglycerides, dl-alpha tocopherol, 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:

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.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8408 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION:

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

HOW SUPPLIED:

PreferaOB® is supplied in a child-resistant bottle of 90 tablets (NDC 0037-0084-90).

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).

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

Distributed by:
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

© 2013 Meda Pharmaceuticals Inc.

U.S. Patent Nos. 7,585,527 and 8,080,520.

Proferrin® is a registered trademark of Colorado BioLabs, Inc., Cozad, NE.
IN-6884-03     Rev 8/2013

PRINCIPAL DISPLAY PANEL – 90 TABLETS LABEL

NDC 0037-0084-90

PreferaOB®

Distributed by:
MEDA
PHARMACEUTICALS™
Somerset, New Jersey 08873-4120

US Patent Nos. 7,585,527 and 8,080,502

©2013 Meda Pharmaceuticals Inc.

Rx Only

90 Tablets

PreferaOB 
cholecalciferol, .alpha.-tocopherol succinate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, d-, iron sucrose, heme iron polypeptide, potassium iodide, zinc oxide, sodium selenate, cupric sulfate tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0037-0084
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL SUCCINATE, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL SUCCINATE, D- 10 [iU]
THIAMINE MONONITRATE (THIAMINE ION) THIAMINE 1.5 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.6 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 17 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 50 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
BIOTIN (BIOTIN) BIOTIN 30 ug
CALCIUM PANTOTHENATE (CALCIUM CATION) CALCIUM CATION 10 mg
IRON SUCROSE (FERRIC CATION) FERRIC CATION 28 mg
HEME IRON POLYPEPTIDE (FERROUS CATION) FERROUS CATION 6 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 250 ug
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 4.5 mg
SODIUM SELENATE (SELENATE ION) SELENIUM 65 ug
CUPRIC SULFATE (CUPRIC CATION) CUPRIC CATION 0.8 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
CROSCARMELLOSE SODIUM  
CROSPOVIDONE  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
SUCROSE  
ETHYLCELLULOSES  
SODIUM ASCORBATE  
MEDIUM-CHAIN TRIGLYCERIDES  
.ALPHA.-TOCOPHEROL, DL-  
POLYVINYL ALCOHOL  
POLYETHYLENE GLYCOLS  
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
# Item Code Package Description
1 NDC:0037-0084-90 90 TABLET, COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 04/28/2015
Labeler - MEDA Pharmaceuticals (051229602)
Revised: 04/2015
 
MEDA Pharmaceuticals
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