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Name:Nestabsprenatal Multi-vitamin/mineral Supplement
Manufacturer:Womens Choice Pharmaceuticals Llc
Category:Prescription Marketed Drugs


Nestabs

NESTABS PRENATAL MULTI-VITAMIN/MINERAL SUPPLEMENT - sodium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous bisglycinate, potassium iodide, zinc oxide and choline bitartrate tablet, film coated 
WOMENS CHOICE PHARMACEUTICALS LLC

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.

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Nestabs


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.

Description: Nestabs tablets for oral administration is a light pink capsule shaped film coated tablet with a pleasant sweet flavor with WC001 imprinted on one side of the tablet.

Indications and Usage:  Nestabs is indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.  Nestabs 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:  Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

 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.

Dosage and Administration:  One tablet daily or as directed by a physician.

NESTABS BOTTLE LABEL


NESTABS  PRENATAL MULTI-VITAMIN/MINERAL SUPPLEMENT
multi-vitamin/mineral supplement with 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, and choline bitartrate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50967-219
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  
CARNAUBA WAX  
Product Characteristics
Color pink (WC;001) Score no score
Shape OVAL Size 18mm
Flavor Imprint Code WC;001
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50967-219-90 1 TABLET, FILM COATED ( TABLET) in 1 BOTTLE, PLASTIC None

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



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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