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NDC 50967-0410-30 Nestabs ONE 225; 18; 6.25; 15; 1; 38; 15; 30; 10; 1 mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 Details
Nestabs ONE 225; 18; 6.25; 15; 1; 38; 15; 30; 10; 1 mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1
Nestabs ONE is a ORAL CAPSULE, GELATIN COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Womens Choice Pharmaceuticals, LLC. The primary component is ANTAZOLINE; CALCIUM ASCORBATE; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE; TOCOPHEROL; ZINC OXIDE.
Product Information
| NDC | 50967-0410 |
|---|---|
| Product ID | 50967-410_dcb3cd24-0cd5-72d8-e053-2a95a90a3016 |
| Associated GPIs | 78516061000145 |
| GCN Sequence Number | 077697 |
| GCN Sequence Number Description | multivit no.42/iron/folate/dha CAPSULE 38-1-225MG ORAL |
| HIC3 | C6Z |
| HIC3 Description | MULTIVITAMIN PREPARATIONS |
| GCN | 43803 |
| HICL Sequence Number | 044484 |
| HICL Sequence Number Description | MULTIVIT 42/IRON CARBONYL,B-G CHE/METHYLTETRAHYDROFOLATE/DHA |
| Brand/Generic | Brand |
| Proprietary Name | Nestabs ONE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Vitamin C, Vitamin D, Vitamin E, Vitamin B6, Folate, Vitamin B12, Iron, Zinc, Magnesium, DHA |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, GELATIN COATED |
| Route | ORAL |
| Active Ingredient Strength | 225; 18; 6.25; 15; 1; 38; 15; 30; 10; 1 |
| Active Ingredient Units | mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1 |
| Substance Name | ANTAZOLINE; CALCIUM ASCORBATE; CHOLECALCIFEROL; CYANOCOBALAMIN; FOLIC ACID; IRON; MAGNESIUM OXIDE; PYRIDOXINE HYDROCHLORIDE; TOCOPHEROL; ZINC OXIDE |
| Labeler Name | Womens Choice Pharmaceuticals, LLC |
| Pharmaceutical Class | Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 50967-0410-30 (50967041030)
| NDC Package Code | 50967-410-30 |
|---|---|
| Billing NDC | 50967041030 |
| Package | 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (50967-410-30) |
| Marketing Start Date | 2017-07-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9b71b219-91ae-46b2-8fb5-d3d118d73873 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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)
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
WARNING
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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.
INGREDIENTS AND APPEARANCE
| NESTABS ONE
vitamin c, vitamin d, vitamin e, vitamin b6, folate, vitamin b12, iron, zinc, magnesium, dha capsule, gelatin coated |
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| Labeler - Womens Choice Pharmaceuticals, LLC (833067841) |