Nestabs One

Nestabs One
SPL v7
SPL
SPL Set ID 9b71b219-91ae-46b2-8fb5-d3d118d73873
Route
ORAL
Published
Effective Date 2017-07-20
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (1 mg) Folic Acid (225 mg) Antazoline (10 mg) Tocopherol (18 mg) Ascorbic Acid (15 ug) Cyanocobalamin (15 mg) Magnesium Cation (6.25 ug) Cholecalciferol (30 mg) Pyridoxine (38 mg) Iron
Inactive Ingredients
Docusate Sodium White Wax Lecithin, Soybean Water Gelatin Type B Bovine (160 Bloom) Glycerin Fd&c Red No. 40 Titanium Dioxide Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: ONE Shape: oval Color: purple Size: 18 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2017-07-20

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.


Medication Information

Recent Major Changes

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 and Precautions

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.

Indications and 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.

Dosage and Administration

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

Dosage Forms and Strengths

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.

Contraindications

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

ingredients.

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.

Section 34084-4

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

Section 42232-9

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

Section 43678-2

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)

Section 44425-7

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

Section 51727-6



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.

Section 51945-4


Structured Label Content

Recent Major Changes (34066-1)

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

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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

Dosage Forms and Strengths (34069-5)

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.

Contraindications (34070-3)

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

ingredients.

Warnings and Precautions (34071-1)

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.

Section 34084-4 (34084-4)

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

Description (34089-3)

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

Section 42232-9 (42232-9)

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

Section 43678-2 (43678-2)

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)

Section 44425-7 (44425-7)

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

Section 51727-6 (51727-6)



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.

Section 51945-4 (51945-4)


Advanced Ingredient Data


Raw Label Data

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