Nestabs ONE

Manufacturer
Womens Choice Pharmaceuticals, LLC
Effective date
2025-04-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 21:32:20

Label at a glance#

ProductNestabs ONE
Active ingredientZINC OXIDE, FOLIC ACID, ANTAZOLINE, TOCOPHEROL, CALCIUM ASCORBATE, CYANOCOBALAMIN, MAGNESIUM OXIDE, CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, IRON
Label structure14 sections

Boxed warning

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

Storage and handling

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

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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 SECTION

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 SECTION


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 SECTION

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 SECTION

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

BOXED WARNING SECTION

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 SECTION

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 SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

HOW SUPPLIED SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PIPI

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CHOLECALCIFEROL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50967-410-302024-08-08C16284748780-19d75b9cf-dbbc-f424-e053-dadaa90a57ceNestabs One
50967-410-302023-07-28C16284748780-19d75b9cf-dbbc-f424-e053-dadaa90a57ceNestabs One
50967-410-302020-09-29C16284748780-19d75b9cf-dbbc-f424-e053-dadaa90a57ceNestabs One
50967-410-302020-01-31C16284748780-19d75b9cf-dbbc-f424-e053-dadaa90a57ceNestabs One

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50967-410-30Nestabs ONE30 in 1 BOTTLE, PLASTICCAPSULE, GELATIN COATED307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50967-410NESTABS ONE (VITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B6, FOLATE, VITAMIN B12, IRON, ZINC, MAGNESIUM, DHA) CAPSULE, GELATIN COATED [WOMENS CHOICE PHARMACEUTICALS, LLC]7Current NDC, Legacy NDC, 1 package rows20250429_9b71b219-91ae-46b2-8fb5-d3d118d73873.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50967-410-30EA - Each50967-4107febebb0-6da2-4e13-85d8-9374f4fa350812017-10-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50967-41050967-410-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nestabs ONEVITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B6, FOLATE, VITAMIN B12, IRON, ZINC, MAGNESIUM, DHAWomens Choice Pharmaceuticals, LLC9b71b219-91ae-46b2-8fb5-d3d118d738732025-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 50967-410-30
ndc (product): 50967-410
ndc11 (package): 50967041030
spl id: 33de431c-2a3a-cab1-e063-6394a90a4feb
spl set id: 9b71b219-91ae-46b2-8fb5-d3d118d73873

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.