NESTABS ONE- vitamin c, vitamin d, vitamin e, vitamin b6, folate, vitamin b12, iron, zinc, magnesium, dha capsule, gelatin coated

Nestabs ONE by

Drug Labeling and Warnings

Nestabs ONE by is a Prescription medication manufactured, distributed, or labeled by Womens Choice Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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

DOSAGE FORMS & STRENGTHS

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)

INACTIVE INGREDIENT

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.

INDICATIONS & USAGE

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

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

BOXED WARNING

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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

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

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

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

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

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

HOW SUPPLIED

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.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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	Item Code (Source)	NDC: 50967-410
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	38 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
ANTAZOLINE (UNII: DHA8014SS1) (ANTAZOLINE - UNII:DHA8014SS1)	ANTAZOLINE	225 mg
TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8)	TOCOPHEROL	10 mg
CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	18 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	15 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM CATION	15 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	6.25 ug
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	30 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)
GLYCERIN (UNII: PDC6A3C0OX)
FD&C RED NO. 40 (UNII: WZB9127XOA)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
WHITE WAX (UNII: 7G1J5DA97F)

Product Characteristics
Color	purple (Opaque)	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	ONE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50967-410-30	30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/2017

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	Business Operations
Womens Choice Pharmaceuticals, LLC		833067841	manufacture(50967-410)