Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameVITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B6, FOLATE, VITAMIN B12, IRON, ZINC, MAGNESIUM, DHA
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
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
Uses described in the label
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 — label text
DOSAGE AND ADMINISTRATION : One softgel taken orally each day, or as directed by a physician.
Forms and 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)
Contraindications
CONTRAINDICATIONS : This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.
Adverse reactions
ADVERSE REACTIONS : Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Product 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.
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.
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.
Storage and handling
STORAGE : Store between 15-30°C (59°-86°F). Protect from extreme temperatures. Freezing & excessive heat may damage softgels.
Supply and packaging
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.
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.