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Nestabs One Prescribing Information

Package insert / product label
Generic name: multi-vitamin/mineral supplement
Dosage form: capsule

Medically reviewed by Drugs.com. Last updated on May 11, 2022.

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

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.

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.

label

PI

NESTABS ONE
vitamin c, vitamin d, vitamin e, vitamin b6, folate, vitamin b12, iron, zinc, magnesium, dha capsule, gelatin coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50967-410
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON38 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
ANTAZOLINE (UNII: DHA8014SS1) (ANTAZOLINE - UNII:DHA8014SS1) ANTAZOLINE225 mg
TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL10 mg
CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID18 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN15 ug
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM CATION15 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL6.25 ug
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE30 mg
Inactive Ingredients
Ingredient NameStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
WHITE WAX (UNII: 7G1J5DA97F)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
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)
Product Characteristics
Colorpurple (Opaque) Scoreno score
ShapeOVALSize18mm
FlavorImprint CodeONE
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50967-410-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/20/2017
Labeler - Womens Choice Pharmaceuticals, LLC (833067841)