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Nestabs ONE Package Insert

Status:
Prescription (Rx) Boxed warning Facts
Strength:
1 mg, 1 mg, 225 mg, 10 mg, 18 mg, 15 mcg, 15 mg, 6.25 mcg, 30 mg, 38 mg
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Nestabs ONE

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.

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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Drug information for Nestabs ONE

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Calculi Dissolution Agent, Osmotic Laxative, Vitamin B12, Vitamin B6 Analog, Vitamin C, Vitamin D
Active ingredients Zinc oxide 1 mg, Folic acid 1 mg, Antazoline 225 mg, Tocopherol 10 mg, Calcium ascorbate 18 mg, Cyanocobalamin 15 mcg, Magnesium oxide 15 mg, Cholecalciferol 6.25 mcg, Pyridoxine hydrochloride 30 mg, Iron 38 mg
Dosage form Capsule, gelatin coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) Womens Choice Pharmaceuticals, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
1 mg, 1 mg, 225 mg, 10 mg, 18 mg, 15 mcg, 15 mg, 6.25 mcg, 30 mg, 38 mg – 30 in 1 bottle, plastic NDC 50967-410-30

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.