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Nestabs One

Generic Name: multi-vitamin/mineral supplement
Dosage Form: capsule

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.

DESCRIPTION: Nestabs® One is a prescription prenatal multi-vitamin/mineral in the form of a purple, opaque softgel capsule imprinted “ONE” for oral administration.

Each NESTABS® ONE Softgel contains:
Vitamin C (as calcium ascorbate) 18 mg
Vitamin D (as cholecalciferol) 6.25 mcg
Vitamin E (as d-alpha tocopheryl acetate) 10 mg
Vitamin B6 (as pyridoxine HCl) 30 mg
Folate (as (6S)-5 1 mg DFE*
-methyltetrahydrofolate -Quatrefolic®) ‡
Vitamin B12 (as cyanocobalamin) 15 mcg
Iron (as carbonyl iron and ferrous 38 mg
bis-glycinate chelate -Ferrochel®) ‡‡
Zinc (as zinc oxide) 20 mg
Magnesium (as magnesium oxide) 15 mg
DHA (Docosahexaenoic Acid from Algal Oil) 225 mg
*Dietary Folate Equivalent (DFE)


Other Ingredients: Gelatin capsule (bovine gelatin, glycerin, purified water, titanium dioxide, FD&C Red #40, FD&C Blue #1), soy lecithin, docusate sodium, white beeswax.
Contains Soy.

INDICATION AND USAGE: Nestabs® One is a prescription prenatal multi-vitamin/mineral supplement with DHA that can be taken throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers.
Nestabs® One may also be useful in improving the nutritional status of women prior to conception. The usual dose is one softgel daily, or as directed by a physician.

CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the
ingredients.

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

WARNINGS: Ingestion of more than 3 grams of omega-3 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.

PRECAUTIONS: Folic acid in doses above 0.1mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

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

DOSAGE AND ADMINISTRATION: One softgel taken orally each day, or as directed by a physician.

STORAGE: Store between 15-30°C (59°-86°F). Protect from extreme temperatures. Freezing & excessive heat may damage softgels.

HOW SUPPLIED: Nestabs® One softgels for oral
administration are supplied in child resistant bottles
containing 30 softgels, Item 50967-410-30 and as
professional samples, Item 50967-410-03.


Rx


To report a serious adverse event or obtain product information, contact 1-800-664-1490.


Distributed By:
Womens Choice Pharmaceuticals, LLC
Berwyn, PA 19312
www.wcpharma.com


Nestabs® is a registered trademark of
Womens Choice Pharmaceuticals, LLC
‡ Quatrefolic® under exclusive license from
Gnosis, S.p.A covered by U.S. Patent No. 7,947,662
and patents pending PCT/EP2008/052037
and PCT/EP2008/052034
‡‡ Ferrochel® is a registered trademark of
Albion Laboratories, Inc., covered by
U.S. Patents 6,716,814 and 7,838,042.

Nestabs One 
vitamin c, vitamin d, vitamin e, vitamin b6, folate, vitamin b12, iron, zinc, magnesium, dha capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50967-410
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRON (IRON) IRON 38 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 1 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
ANTAZOLINE (ANTAZOLINE) ANTAZOLINE 225 mg
TOCOPHEROL (TOCOPHEROL) TOCOPHEROL 10 mg
CALCIUM ASCORBATE (ASCORBIC ACID) ASCORBIC ACID 18 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 15 ug
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM CATION 15 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 6.25 ug
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 30 mg
Inactive Ingredients
Ingredient Name Strength
WATER  
GELATIN TYPE B BOVINE (160 BLOOM)  
GLYCERIN  
FD&C RED NO. 40  
TITANIUM DIOXIDE  
FD&C BLUE NO. 1  
LECITHIN, SOYBEAN  
DOCUSATE SODIUM  
WHITE WAX  
Product Characteristics
Color purple (Opaque) Score no score
Shape OVAL Size 18mm
Flavor Imprint Code ONE
Contains     
Packaging
# Item Code Package Description
1 NDC:50967-410-30 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/20/2017
Labeler - Womens Choice Pharmaceuticals, LLC (833067841)
Establishment
Name Address ID/FEI Operations
Womens Choice Pharmaceuticals, LLC 833067841 manufacture(50967-410)
Revised: 08/2017
 
Womens Choice Pharmaceuticals, LLC
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