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PreferaOB One

Generic Name: prenatal - postnatal multivitamin - multimineral
Dosage Form: softgel capsule

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/
DHA softgel

Rx Only

DESCRIPTION:

PreferaOB One® is a prescription prenatal/postnatal multivitamin/multimineral nutritional supplement with Omega-3 fatty acid (life’sDHA™*). PreferaOB One® is an oblong shaped, opaque purple colored softgel, imprinted "AP 86" in white ink on one side and plain on the other.

Each PreferaOB One® Softgel contains:

VITAMINS MINERALS
C (as ascorbic acid)……………………..25 mg
D3 (as cholecalciferol) ............................ 400 IU

E (as dl-alpha tocopheryl acetate).……… 10 IU
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………………………….28 mg
  (as PIC -
  polysaccharide iron complex)

  (as HIP - heme iron polypeptide
  as Proferrin®**)


Iodine (as potassium iodide)175 mcg
Zinc (as zinc oxide) ................ 15 mg

OMEGA-3 FATTY ACID
Docosahexaenoic Acid (DHA)…………200 mg

200 mg of DHA from 500 mg of algal oil derived from Crypthecodinium cohnii.

life’sDHA Oil includes: DHA algal oil, high oleic sunflower oil, ascorbyl palmitate (vitamin A) & tocopherols (as antioxidants).

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.

Other Ingredients: Gelatin, soybean oil, yellow beeswax, lecithin, D&C red #33, FD&C blue #1, titanium dioxide and purified water.

INDICATIONS AND USAGE:

PreferaOB One® is a prescription multivitamin/multimineral nutritional supplement with Omega-3 fatty acid (life’sDHA) 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 One® 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 1-877-999-8410 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION:

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

HOW SUPPLIED:

PreferaOB One® is supplied in child-resistant blister packs of 30 softgels
(NDC 0037-0086-30).

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

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.

© 2015 Meda Pharmaceuticals Inc.

IN-6886-05    Rev 7/2015

PRINCIPAL DISPLAY PANEL – 30 SOFTGELS CARTON

Rx Only

NDC 0037-0086-30

PreferaOB One®

Pre/Post-natal Nutritional
Supplement + DHA

HEME Iron

Non-HEME
Iron

50 mg
Vitamin B6

1 mg
Folic Acid

life'sDHA

30 Softgels

PreferaOB One 
ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, d-, iron sucrose, heme iron polypeptide, potassium iodide, zinc oxide, schizochytrium dha oil capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0037-0086
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 25 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 10 [iU]
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 22 mg
HEME IRON POLYPEPTIDE (FERROUS CATION) FERROUS CATION 6 mg
POTASSIUM IODIDE (IODIDE ION) POTASSIUM IODIDE 175 ug
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 15 mg
SCHIZOCHYTRIUM DHA OIL (DOCONEXENT) DOCONEXENT 200 mg
Inactive Ingredients
Ingredient Name Strength
SUNFLOWER OIL  
ASCORBYL PALMITATE  
TOCOPHEROL  
GELATIN  
SOYBEAN OIL  
YELLOW WAX  
LECITHIN, SOYBEAN  
D&C RED NO. 33  
FD&C BLUE NO. 1  
TITANIUM DIOXIDE  
WATER  
Product Characteristics
Color PURPLE Score no score
Shape OVAL Size 25mm
Flavor Imprint Code AP;86
Contains         
Packaging
# Item Code Package Description
1 NDC:0037-0086-30 30 BLISTER PACK in 1 CARTON
1 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
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: 10/2015
 
MEDA Pharmaceuticals
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