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Nestabs Prenatal

Generic Name: multi-vitamin/mineral supplement
Dosage Form: tablets / softgel 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.

NESTABS ABC Prenatal Multi-vitamin/Mineral Tablet

Descripton:   Nestabs ABC combination tablet-capsule for oral administration is a light green capsule-shaped film coated tablet with a pleasant sweet flavor with WC003 imprinted on one side of the tablet and a light amber soft gel capsule omega-3 fatty acid containing both DHA and EPA.

Indications and Usage: Nestabs ABC 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.

Warnings: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where 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 ABC - One tablet and one soft gel capsule daily or as directed by a physician.

How Supplied:  Nestabs ABC tablets for oral administration are supplied as six child-resistant blister cards containing 5 tablets and 5 softgel capsules each (NDC# 50967-309-30).

Nestabs DHA

Prenatal Multi-vitamin/Mineral Supplement

Gluten Free

NDC 509*67-317-30 (30 count)

6 blister cards

each containing 5 tablets and 5 capsules

877-774-4949

www.wcpharma.com

 

NESTABS ABC  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:50967-309
Packaging
# Item Code Package Description
1 NDC:50967-309-30 6 BLISTER PACK in 1 CARTON
1 1 KIT (KIT) in 1 BLISTER PACK
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1
Part 2
Part 1 of 2
NESTABS ABC  MULTI-VITAMIN/MINERAL SUPPLEMENT
sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, polysaccharide iron complex, 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
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 450 [iU]
TOCOPHERSOLAN (TOCOPHERSOLAN) TOCOPHERSOLAN 30 [iU]
THIAMINE (THIAMINE ION) THIAMINE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
NIACIN (NIACIN) NIACIN 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 50 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 10 ug
CALCIUM (CALCIUM) CALCIUM 155 mg
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CATION 45 mg
IRON (IRON) IRON 32 mg
POTASSIUM IODIDE (IODIDE ION) IODIDE ION 100 ug
ZINC (ZINC) ZINC 10 mg
CHOLINE BITARTRATE (CHOLINE) CHOLINE 55 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
HYDROXYPROPYL CELLULOSE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
MAGNESIUM STEARATE  
MALTODEXTRIN  
TALC  
SACCHARIN  
Product Characteristics
Color green (LIGHT GREEN) Score 2 pieces
Shape OVAL Size 18mm
Flavor Imprint Code WC;003
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2013
Part 2 of 2
NESTABS ABC 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 120 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT 180 mg
ALPHA-TOCOPHEROL, D- (.ALPHA.-TOCOPHEROL, D-) ALPHA-TOCOPHEROL, D- 2 [iU]
Inactive Ingredients
Ingredient Name Strength
GELATIN  
GLYCERIN  
WATER  
Product Characteristics
Color yellow Score no score
Shape capsule Size 9mm
Flavor Imprint Code
Contains         
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/01/2013
Labeler - WOMENS CHOICE PHARMACEUTICALS LLC (833067841)
Registrant - WOMENS CHOICE PHARMACEUTICALS LLC (833067841)
Revised: 09/2013
 
WOMENS CHOICE PHARMACEUTICALS LLC



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