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PreferaOB plus DHA

Generic Name: prenatal - postnatal multivitamin - multimineral
Dosage Form: tablets, sofgel capsules

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.

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 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

MINERALS
Iron………………………..............................................34 mg
  (as PIP - polysaccharide iron complex)
  (as HIP - heme iron polypeptide as Proferrin®**)
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

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).

Each life’sDHA Softgel contains:
Docosahexaenoic Acid (DHA)…….200 mg
200 mg of DHA from 500 mg of algal oil derived from Crypthecodinium cohnii
Ingredients include: DHA algal oil, high oleic sunflower oil, ascorbyl palmitate (vitamin A) & tocopherols (as antioxidants) in a gelatin capsule (gelatin, glycerin, water, caramel color, carmine, calcium carbonate and turmeric).
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.

Indications and Usage for PreferaOB plus DHA

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 0.1 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 1-877-999-8409 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PreferaOB plus DHA 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 is PreferaOB plus DHA Supplied

PreferaOB+DHA® is supplied in child-resistant blister packs of 30 tablets and 30 softgels (NDC 0037-0083-30). Each blister unit contains one tablet and one softgel.

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).

To protect from light, dispense in carton provided. Once open, blisters should be stored in carton.

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

© 2015 Meda Pharmaceuticals Inc.                    70010893

U.S. Patent Nos. 7,585,527 and 8,080,520.
*life’sDHA is a trademark of Martek Biosciences Corporation, Columbia, MD.
**Proferrin® is a registered trademark of Colorado BioLabs, Inc., Cozad, NE.
IN-6883-04     Rev. 7/2015

PRINCIPAL DISPLAY PANEL - 30 TABLETS + 30 SOFTGELS BLISTER PACK


PRINCIPAL DISPLAY PANEL - 30 TABLETS + 30 SOFTGELS BLISTER PACK - TABLET/SOFTGEL LAYOUT


PRINCIPAL DISPLAY PANEL - 30 TABLETS + 30 SOFTGELS CARTON

Rx Only

NDC 0037-0083-30

PreferaOB
+ DHA®

Pre/Post-natal Nutritional
Supplement + DHA

HEME Iron

Non-HEME
Iron

50 mg
Vitamin B6

1 mg
Folic Acid

life'sDHA™

30 Tablets + 30 Softgels

PreferaOB plus DHA 
prenatal/postnatal multivitamin/multimineral kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0037-0083
Packaging
# Item Code Package Description
1 NDC:0037-0083-30 30 BLISTER PACK in 1 CARTON
1 NDC:0037-0083-05 1 KIT in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1
Part 2
Part 1 of 2
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
     
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         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/01/2015
Part 2 of 2
LIFESDHA 
schizochytrium dha oil capsule, liquid filled
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SCHIZOCHYTRIUM DHA OIL (DOCONEXENT) DOCONEXENT 200 mg
Inactive Ingredients
Ingredient Name Strength
SUNFLOWER OIL  
ASCORBYL PALMITATE  
TOCOPHEROL  
GELATIN  
WATER  
CARAMEL  
CARMINIC ACID  
CALCIUM CARBONATE  
TURMERIC  
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 15mm
Flavor Imprint Code
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/01/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 02/01/2015
Labeler - MEDA Pharmaceuticals (051229602)
Revised: 11/2015
 
MEDA Pharmaceuticals
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