ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
BOXED WARNING SECTION.
WARNING: Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under years of age. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call doctor or poison control center immediately.
CONTRAINDICATIONS: This product is contraindicated in patients with known hypersensitivity to any of the ingredients.
DESCRIPTION: Nestabs(R) One is prescription prenatal multi-vitamin/mineral in the form of purple, opaque softgel capsule imprinted ONE for oral administration.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION: One softgel taken orally each day, or as directed by physician.
DOSAGE FORMS & STRENGTHS SECTION.
Each NESTABS(R) ONE Softgel contains:Vitamin (as calcium ascorbate) 18 mg Vitamin (as cholecalciferol) 6.25 mcg Vitamin (as d-alpha tocopheryl acetate) 10 mg Vitamin B6 (as pyridoxine HCl) 30 mg Folate (as (6S)-5 mg DFE -methyltetrahydrofolate -Quatrefolic(R)) Vitamin B12 (as cyanocobalamin) 15 mcg Iron (as carbonyl iron and ferrous 38 mg bis-glycinate chelate -Ferrochel(R)) Zinc (as zinc oxide) 20 mg Magnesium (as magnesium oxide) 15 mg DHA (Docosahexaenoic Acid from Algal Oil) 225 mg Dietary Folate Equivalent (DFE).
HOW SUPPLIED SECTION.
HOW SUPPLIED: Nestabs(R) 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. RxTo report 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(R) is registered trademark of Womens Choice Pharmaceuticals, LLC Quatrefolic(R) 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(R) is registered trademark of Albion Laboratories, Inc., covered by U.S. Patents 6,716,814 and 7,838,042.
INULLCTIVE 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(R) One is 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(R) 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 physician.
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 SECTION.
STORAGE: Store between 15-30C (59-86F). Protect from extreme temperatures. Freezing excessive heat may damage softgels.
WARNINGS: Ingestion of more than 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.