Nestabs® DHA Prenatal Multi-vitamin/Mineral Tablets with DHA and Choline Nestabs® Prenatal Multi-vitamin/Mineral Tablets with Choline Description: Nestabs® DHA combination tablet-capsule for oral administration is a light pink capsule-shaped film coated tablet with a pleasant sweet flavor with WC001 imprinted on one side of the tablet and a enteric coated light amber soft gel capsule omega-3 fatty acid containing both DHA and EPA. Nestabs® tablets for oral administration is a light pink capsule-shaped film coated tablet with a pleasant sweet flavor with WC001 imprinted on one side of the tablet. Each tablet contains: DOSE
% DV*
Vitamin C (Sodium Ascorbate) ................................................................. 120 mg Vitamin D-3 (Cholecalciferol)..................................................................... 450 IU Vitamin E (dl-alpha-Tocopheryl Acetate) ..................................................... 30 IU Vitamin B-1 (Thiamine Mononitrate)............................................................. 3 mg Vitamin B-2 (Riboflavin)................................................................................ 3 mg Niacin (Niacinamide) .................................................................................. 20 mg Vitamin B-6 (Pyridoxine HCL)..................................................................... 50 mg Folic Acid .............................................................................................. 1000 mcg Vitamin B-12 (Cyanocobalamin)............................................................... 10 mcg Calcium..................................................................................................... 200 mg as Formical® (Calcium Formate 155 mg) (Calcium Carbonate 45 mg) Iron (Ferrous (II) bis-Glycinate Chelate) ..................................................... 32 mg Iodine (Potassium Iodide)....................................................................... 100 mcg Zinc (Zinc Oxide) ........................................................................................ 10 mg Choline (Choline Bitartrate) ........................................................................ 55 mg
INGREDIENT
200% 112% 100% 176% 150% 100% 2000% 125% 125% 15%
* % Daily Value for Pregnant and Lactating Women
178% 67% 67% **
** DV Not Established
Other Ingredients: Microcrystalline Cellulose, Magnesium Stearate, Povidone, Polyvinyl Alcohol-Partially Hydrolyzed, PEG 3350, Titanium Dioxide, Talc, FD&C Red #40 Aluminum Lake, Saccharin, Carnauba Wax.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Each Omega-3 DHA gelatin capsule contains: Docosahexaenoic Acid (DHA) 230 mg and Eicosapentaenoic Acid (EPA) 30 mg derived from fish oils (product of Norway). Other ingredients in the DHA gelatin capsule: Vitamin E (d-alpha-tocopherols) 2 IU, gelatin, glycerin, purified water. Indications and Usage: Nestabs® DHA is indicated to provide vitamin/mineral and omega-3 fatty acid supplementation to women throughout pregnancy, during the postnatal for both lactating and nonlactating mothers. Nestabs® DHA is also beneficial in improving the nutritional status of women prior to conception.
Nestabs® tablets include 14 essential vitamins, minerals, and trace elements to adequately supplement mothers and unborn children. ••••• Nestabs® is nutritionally complete and was carefully formulated using recommendations from the American College of Obstetrics and Gynecology and the Center for Disease Control
Prenatal Multi-vitamin/Mineral Tablet
••••• Nestabs® is a well tolerated film coated tablet with a pleasant sweet flavor ••••• Nestabs® is a Kosher certified tablet, Gluten free and Vegetarian
Nestabs® is indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. Nestabs® is also beneficial in improving the nutritional status of women prior to conception. Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. 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: Nestabs DHA - One tablet and one soft gel capsule daily or as directed by a physician. Nestabs® - One tablet daily or as directed by a physician. ®
How Supplied: Nestabs DHA tablets for oral administration are supplied as six child-resistant blister cards containing 5 tablets and 5 softgel capsules each (NDC # 50967-317-30). Samples are in blister cards containing 3 tablets and 3 soft gel capsules each (NDC # 50967-317-03). ®
Nestabs® tablets for oral administration are supplied in bottles of 90 tablets (NDC # 50967-219-90). Samples are in blister cards containing 3 tablets (NDC # 50967-219-03). Store at controlled room temperature 15°- 30°(59°- 86°F) RX only
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Nestab
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Nestab
LABEL REFILL
Dr. John Doe SE AS
Distributed by: Women’s Choice Pharmaceuticals ▪ Gilbert, AZ 85233 ▪ (877) 774-4949
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50 Years
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WRITTE
Formical® is a registered trademark of Nephro-Tech 1, LLC US Patent #6,528,542, #6,489,361, #6,160,016 Nestabs® is a registered trademark of Women’s Choice Pharmaceuticals, LLC NDHA – 01/11
REFERENCES 1 Data on file, Womens Choice Pharmaceuticals 2 Coplin M, Schuette S, Leichtmann G, Lashner B. Tolerability of iron: a comparison of bis-glycino iron II and ferrous sulfate. Clin Ther. 1991 Sep-Oct;13(5):606-12 3 Center for Disease Control and Prevention. Recommendations for use of Folic Acid to reduce number of spina bifida cases and other neural tube defects, MMWR. 1992.41:RR-14. 4 Smut, et al. Obstetrics and Gynecology, 2003; 101:469-79 5 Jensen et al. American Journal of Clinical Nutrition 2005; 82:125-32. 6 Hibbeln JR, Journal of Affective Disorders, May 2002; 69:15-29 7 American College of Obstetricians and Gynecologists (ACOG). Nausea and vomiting of pregnancy. ACOG Practice Bulletin. 2004;52:1-10 8 Sahakian V, Rouse D, Sipes S, Rose N, Niebyl J. Vitamin B6 is an effective therapy for nausea and vomiting of pregnancy, double blind placebo-controlled trial. Ob Gyn.1991; 78: 33-36 9 Vutyavanvanich T, Wongra-ngan S, Ruangsri R. Pyridoxine for nausea and vomiting of pregnancy: a randomized, double-blind placebo-controlled trial. Am J Ob Gyn. 1995; 173: 881-884 10 Zeisel SH: Nutrition; 2000; 16:669-671 11 Zeisel SH: Journal of the American College of Nutrition; 1992; 11:473-481 12 Loy R, Heyer D, Williams CL, Merk WH, Advances in Experimental Medicine and Biology 1991; 295:373-382 13 THE JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS Copyright © 2005 by The American Society for Pharmacology and Experimental Therapeutics JPET 313:1217–1222, 2005
PHARMACEUTICALS
Gilbert, AZ 85233 • (877) 774-4949 • www.wcpharma.com
The Gold Standard Just Got Better
F avor i t e W d l O ith A An N e w F or mu l at ion Calcium Formate
Iron
Choline
Ferrous (II) bis-Glycinate Chelate is a novel form of iron that is easier to absorb, associated with fewer side effects, and less toxic than standard supplements like ferrous sulfate.1 • Clinically proven to reduce negative side effects especially bloating, constipation, and nausea when compared to ferrous sulfate.2 • Compliant with the CDC’s recommendation for preventing and controlling iron deficiency anemia in pregnant women through low dose supplementation
Choline is designated as an essential nutrient by the FDA with supplementation during pregnancy linked to improved memory skills of children. • Influences neural tube closure10 • Plays a critical role in normal brain development11 • May result in lifelong enhancement of memory and attention12
Folic Acid • Folic Acid is shown to significantly reduce the incidence of neural tube defects in unborn babies.3 Vitamin B6 Vitamin B6 is recommended as a first-line therapy for pregnancy-related nausea and vomiting by the American College of Obstetricians and Gynecologists (ACOG)7 • Nestabs® DHA contains 50 mg of vitamin B6 which has been shown to reduce pregnancy-related nausea.8,9
50 Years
DHA Nestabs® DHA features an enteric coated, high quality source of omega-3 acids containing both DHA and EPA. • DHA supplementation during pregnancy and/or nursing provides benefits to both mother and child • Supports gestation progress to full term4 • Improves infant psychomotor developments5 • Lower rates of post partum depression6 • Meets USP safety standards
The Gold Standard Just Got Better
After calcium formate administration, the Cmax and AUC values were double those for calcium citrate. The large and highly significant increases in these parameters indicate that calcium from calcium formate is absorbed much more rapidly and to a much greater extent than calcium from the other calcium preparations studied. ABBREVIATIONS: iPTH, intact parathyroid hormone 1–84; AUC, area under the plasma concentration-time curve
Serum Calcium Percent of Time 0
Prenatal Multi-vitamin/Mineral Tablet
Nestabs® DHA contains FormiCal® a patented source of calcium formate. FormiCal® is superior to both calcium carbonate and calcium citrate in its ability to deliver calcium to the bloodstream and depress iPTH after oral administration.13 • Formical® is clinically proven to be: • More soluble and much more absorbed than other calciums • Avoids bloating common with calcium
120
Ca Formate Placebo Ca Carbonate Ca Citrate
115
110
105
100
0
30
60
90
135
180
Time (min)
225
270