Nestabs DHA Prenatal

Generic Name: multi-vitamin/mineral supplement
Dosage Form: tablet, film coated

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.

NESTABS DHA Prenatal Multi-vitamin/Mineral Tablet

Descripton:   Nestabs DHA combination tablet-capsule for oral administration is a light pink capsule-shaped film coated tablet with a pleasant sweet flavor with WCOO1 imprinted on one side of the tablet and a enteric coated light amber soft gel capsule omega-3 fatty acid containing both DHA and EPA.

Indications and Usage: Nestabs DHA is indicated to provide vitamin/mineral and omega-3 fatty acid supplementation to women throughout pregnancy, during the postnatal for both lactating and nonlactating mothers. Nestabs 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 .

Warnings:  Ingestion of more than 3 grams of omega-fatty acids per day has been shown to have potential antithrombotic effects, including increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.


Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.



WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

Precautions:  Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. This product contains formate, which if consumed above the recommended level, could cause visual impairment and other health effects. Do not take more than the recommended amount. If you are pregnant, nursing, or taking any medications consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur. Not intended for use by persons under the age of 18.

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

Dosage and Administration: Nestabs DHA - One tablet and one soft gel capsule daily or as directed by a physician.

How Supplied:  Nestabs DHA tablets for oral administration are supplied as six child-resistant blister cards containing 5 tablets and 5 softgel capsules each (NDC# 50967-317-30).

NESTABS DHA  PRENATAL MULTI-VITAMIN/MINERAL SUPPLEMENT WITH DHA/EPA
sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous (ii) bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate, with doconexent and icosapent kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50967-317
Packaging
# Item Code Package Description
1 NDC:50967-317-30 4 BLISTER PACK (BLISTER PACK) in 1 CARTON
1 1 KIT (KIT) in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 30 
Part 2 30 
Part 1 of 2
NESTABS  MULTI-VITAMIN/MINERAL SUPPLEMENT
sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous (ii) bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate tablet
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 450 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (TOCOPHERSOLAN) .ALPHA.-TOCOPHEROL ACETATE, D- 30 [iU]
THIAMINE MONONITRATE (THIAMINE) THIAMINE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 50 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 10 ug
CALCIUM FORMATE (CALCIUM) CALCIUM 155 mg
CALCIUM CARBONATE (CARBONATE ION) CARBONATE ION 45 mg
FERROUS BISGLYCINATE (IRON) IRON 32 mg
POTASSIUM IODIDE (POTASSIUM CATION) POTASSIUM CATION 100 ug
ZINC OXIDE (ZINC) ZINC 10 mg
CHOLINE BITARTRATE (CHOLINE) CHOLINE BITARTRATE 55 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
MAGNESIUM STEARATE  
POVIDONE  
POLYVINYL ALCOHOL  
TITANIUM DIOXIDE  
TALC  
FD&C RED NO. 40  
ALUMINUM OXIDE  
SACCHARIN  
Product Characteristics
Color pink Score no score
Shape OVAL Size 18mm
Flavor Imprint Code WC;001
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/01/2011
Part 2 of 2
NESTABS OMEGA 3-DHA  
doconexent and icosapent supplement capsule, gelatin coated
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 230 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 30 mg
ALPHA-TOCOPHEROL, D- (TOCOPHERSOLAN) ALPHA-TOCOPHEROL, D- 2 [iU]
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
WATER  
Product Characteristics
Color yellow Score no score
Shape OVAL Size 6mm
Flavor Imprint Code ;
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 02/01/2011
Labeler - WOMENS CHOICE PHARMACEUTICALS LLC (833067841)
Registrant - WOMENS CHOICE PHARMACEUTICALS LLC (833067841)
Revised: 02/2011
 
WOMENS CHOICE PHARMACEUTICALS LLC



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