Nestabs dhaprenatal multi-vitamin/mineral supplement with dha/epa kit

Description section

D escripton:Nestabs DHA combinationtablet-capsule for oral administration is a light pink capsule-shaped filmcoated tablet with a pleasant sweet flavor with WCOO1 imprinted on one side ofthe tablet and a enteric coated light amber soft gel capsule omega-3 fatty acidcontaining both DHA and EPA.

Indications & usage section

I ndications and Usage:Nestabs DHA is indicatedto provide vitamin/mineral and omega-3 fatty acid supplementation to womenthroughout pregnancy, during the postnatal for both lactating and nonlactatingmothers. Nestabs DHA is also beneficial in improving the nutritional status ofwomen prior to conception.

Contraindications section

C ontraindications:This product is contraindicated in patients with a knownhypersensitivity to any of the ingredients .

Boxed warning section

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

Precautions section

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

Adverse reactions section

A dverse Reactions:Allergic sensitization hasbeen reported following both oral and parenteral administration of folic acid.

Dosage & administration section

D osage and Administration:Nestabs DHA - Onetablet and one soft gel capsule daily or as directed by a physician.

How supplied section

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

Ingredients and appearance - Product information

Nestabs dhaprenatal multi-vitamin/mineral supplement with dha/epa kit- 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

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 50967-317
Route of Administration Oral

Product Characteristics

Color yellow Score 1
Shape OVAL Imprint Code ;
Size 6 mm

Packaging

# Item Code Package Description Marketing Start Date
1 1 BLISTER PACK 2011/02/01
2 NDC: 50967-317-30 4 in 1 CARTON 2011/02/01

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA 2011/02/01

Labeler - WOMENS CHOICE PHARMACEUTICALS LLC( 833067841)

Establishment

Name ID/FEI Business Operations
WOMENS CHOICE PHARMACEUTICALS LLC 833067841 label( 50967-317)