Prefera OB plus DHA description, usages, side effects, indications, overdosage, supplying and lots more!

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Prefera OB plus DHA

Alaven Pharmaceutical LLC

Prefera OB® + DHA The Prenatal YOU CAN COUNT ON!


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Prenatal/Postnatal Multivitamin/Multimineral
PreferaOB ® Tablets & life'sDHA life'sDHA™ is a trademark of Martek Biosciences Corporation, Columbia, MD. Softgels

Rx Only

PREFERA OB PLUS DHA 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/88" 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 MINERALS
D3 (as cholecalciferol) 400 IU Iron
E (as d-alpha tocopheryl succinate) 10 IU   as PIC (polysaccharide iron complex) 22 mg
B1 (as thiamin mononitrate) 1.5 mg   as HIP (heme iron polypeptide as Proferrin® Proferrin® is a registered trademark of Colorado Biolabs, Inc., Cozad, NE.
B2 (as riboflavin) 1.6 mg   bovine source, USDA certified) 6 mg
B3 (niacin as niacinamide) 17 mg Iodine (as potassium iodide) 175 mcg
B6 (as pyridoxine HCl) 50 mg Zinc (as zinc oxide) 15 mg
Folic Acid 1 mg Selenium (as sodium selenate) 65 mcg
B12 (as cyanocobalamin) 12 mcg Copper (as cupric sulfate) 0.8 mg
Biotin 30 mcg
B5 (as d-calcium pantothenate) 10 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).

Each life'sDHA™ Softgel contains:   Docosahexaenoic Acid (DHA)                      200 mg
DHA is derived from the oils of microalgae. Inactive ingredients in the DHA softgel include: gelatin, glycerin USP, water.

PREFERA OB PLUS DHA 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 nonlactating mothers. PreferaOB® + DHA is also beneficial in improving the nutritional status of women prior to conception.

PREFERA OB PLUS DHA 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.

PREFERA OB PLUS DHA ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

PREFERA OB 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 SUPPLIED

PreferaOB® + DHA is supplied in child-resistant blister packs of 30 tablets and 30 softgels (NDC 68220-089-30) and as a Professional Sample (NDC 68220-089-25).

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 30062

Patents Pending

PreferaOB® is a registered trademark of Alaven® Pharmaceutical LLC, Marietta, GA.

089-0709-01
Ref CL-089-0709-01

PRINCIPAL DISPLAY PANEL - 30 Tablets + 30 Softgels Carton

Rx Only

NDC 68220-089-30
30 Tablets + 30 Softgels

PreferaOB®
+ DHA

The Prenatel YOU CAN COUNT ON!

ONLY prenatal with Natural, Body-Ready HEME Iron + DHA

15 Essential Vitamins and Minerals including:

  • – Plant-based life'sDHA™ Omega-3
  • – High dose of vitamin B6
  • – 1mg of folic acid

ACTUAL
SIZE

Pre/Post-natal Nutritional
Supplement + DHA

www.PreferaOB.com

Prefera OB plus DHA

Prefera OB 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 Type Human prescription drug label Item Code (Source) NDC:68220-089
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
FOLIC ACID FOLIC ACID 1 mg
Heme Iron Polypeptide FERRIC CATION 6 mg
IRON DEXTRAN Ferric Cation 22 mg
Potassium Iodide IODIDE ION 175 ug
Zinc Oxide Zinc oxide 15 mg
Selenium SELENIUM 65 ug
CUPRIC SULFATE CUPRIC CATION 0.8 mg
CHOLECALCIFEROL CHOLECALCIFEROL 400 [iU]
THIAMINE MONONITRATE THIAMINE ION 1.5 mg
ALPHA-TOCOPHEROL SUCCINATE, D- ALPHA-TOCOPHEROL SUCCINATE, D- 10 [iU]
RIBOFLAVIN RIBOFLAVIN 1.6 mg
NIACINAMIDE 17 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 50 mg
Cyanocobalamin CYANOCOBALAMIN 12 ug
BIOTIN 30 ug
CALCIUM PANTOTHENATE PANTOTHENIC ACID 10 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
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

Product Characteristics

Color Size Imprint Code Shape
PURPLE 15 mm AP;88 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68220-089-05 5 in 1 BLISTER PACK
2 NDC:68220-089-30 30 in 1 CARTON
3 NDC:68220-089-05 5 in 1 BLISTER PACK
4 NDC:68220-089-25 5 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2009-04-01


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