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- NDC Code(s): 50967-317-30
- Packager: WOMENS CHOICE PHARMACEUTICALS LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated April 28, 2025
If you are a consumer or patient please visit this version.
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- DESCRIPTION
D escripton: Nestabs DHA combinationtablet-capsule for oral administration is a light pink capsule-shaped filmcoated tablet with a pleasant sweet flavor with WCOO1 imprinted on one side ofthe tablet and a enteric coated light amber soft gel capsule omega-3 fatty acidcontaining both DHA and EPA.
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I ndications and Usage: Nestabs DHA is indicatedto provide vitamin/mineral and omega-3 fatty acid supplementation to womenthroughout pregnancy, during the postnatal for both lactating and nonlactatingmothers. Nestabs DHA is also beneficial in improving the nutritional status ofwomen prior to conception.
- CONTRAINDICATIONS
C ontraindications: This product is contraindicated in patients with a knownhypersensitivity to any of the ingredients .
- WARNINGS
W arnings: Ingestion of more than 3 grams of omega-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.
- BOXED WARNING (What is this?)
WARNING: Accidentaloverdose of iron-containing products is a leading cause of fatal poisoning inchildren under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case ofaccidental overdose, call a doctor or poison control center immediately.
- PRECAUTIONS
P recautions: Folic acid in doses above 0.1mg dailymay obscure pernicious anemia in that hematologic remission can occur whileneurological manifestations remain progressive. This product contains formate,which if consumed above the recommended level, could cause visual impairmentand other health effects. Do not take more than the recommended amount. If youare pregnant, nursing, or taking any medications consult your doctor beforeuse. Discontinue use and consult your doctor if any adverse reactions occur.Not intended for use by persons under the age of 18.
- ADVERSE REACTIONS
A dverse Reactions: Allergic sensitization hasbeen reported following both oral and parenteral administration of folic acid.
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D osage and Administration: Nestabs DHA - Onetablet and one soft gel capsule daily or as directed by a physician.
- HOW SUPPLIED
H ow Supplied: Nestabs DHA tablets for oraladministration are supplied as six child-resistant blister cards containing 5tablets and 5 softgel capsules each (NDC# 50967-317-30).
- PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
NESTABS DHAPRENATAL MULTI-VITAMIN/MINERAL SUPPLEMENT WITH DHA/EPA
sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous (ii) bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate, with doconexent and icosapent kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50967-317 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50967-317-30 4 in 1 CARTON 02/01/2011 1 1 in 1 BLISTER PACK Quantity of Parts Part# Package Quantity Total Product Quantity Part 1 30 Part 2 30 Part 1 of 2 NESTABSMULTI-VITAMIN/MINERAL SUPPLEMENT
sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous (ii) bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate tabletProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE ION 3mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 3mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 50mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 10ug CALCIUM FORMATE (UNII: NP3JD65NPY) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 155mg CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 45mg FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 32mg SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 450[iU] ALPHA-TOCOPHERYLQUINONE (UNII: ZO763K43XR) (ALPHA-TOCOPHERYLQUINONE - UNII:ZO763K43XR) ALPHA-TOCOPHERYLQUINONE 30[iU] POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 100ug ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10mg CHOLINE BITARTRATE (UNII: 6K2W7T9V6Y) (CHOLINE - UNII:N91BDP6H0X) CHOLINE 55mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE (UNII: FZ989GH94E) POLYVINYL ALCOHOL (UNII: 532B59J990) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) FD&C RED NO. 40 (UNII: WZB9127XOA) ALUMINUM OXIDE (UNII: LMI26O6933) SACCHARIN (UNII: FST467XS7D) Product Characteristics Color pink Score no score Shape OVAL Size 18mm Flavor Imprint Code WC;001 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/01/2011 Part 2 of 2 NESTABS OMEGA 3-DHA
doconexent and icosapent supplement capsule, gelatin coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT 230mg ICOSAPENT (UNII: AAN7QOV9EA) (ICOSAPENT - UNII:AAN7QOV9EA) ICOSAPENT 30mg .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D- 2[iU] Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Product Characteristics Color yellow Score no score Shape OVAL Size 6mm Flavor Imprint Code ; Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/01/2011 Labeler -WOMENS CHOICE PHARMACEUTICALS LLC(833067841)
Registrant -WOMENS CHOICE PHARMACEUTICALS LLC (833067841)
Establishment Name Address ID/FEI Business Operations Women's Choice Pharmaceuticals 833067841 label(50967-317)
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NESTABS DHA PRENATAL MULTI-VITAMIN/MINERAL SUPPLEMENT WITH DHA/EPA (sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous- ii bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate, with doconexent and icosapent kit
Number of versions: 6
| Published Date (What is this?) | Version | Files |
|---|---|---|
| Apr 29, 2025 | 6 (current) | download |
| Jan 19, 2023 | 5 | download |
| Dec 31, 2021 | 4 | download |
| Sep 30, 2020 | 3 | download |
| Nov 23, 2018 | 2 | download |
| Jul 12, 2011 | 1 | download |
RxNorm
NESTABS DHA PRENATAL MULTI-VITAMIN/MINERAL SUPPLEMENT WITH DHA/EPA (sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous- ii bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate, with doconexent and icosapent kit
Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. Out of scope information includes radiopharmaceuticals, contrast media, herbals, homeopathics, and food. Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope.
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NESTABS DHA PRENATAL MULTI-VITAMIN/MINERAL SUPPLEMENT WITH DHA/EPA (sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous- ii bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate, with doconexent and icosapent kit
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NDC Codes
NESTABS DHA PRENATAL MULTI-VITAMIN/MINERAL SUPPLEMENT WITH DHA/EPA (sodium ascorbate, cholecalciferol, di-alpha-tocopheryl acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hcl, folic acid, cyanocobalamin, calcium formate, calcium carbonate, ferrous- ii bis-glycinate chelate, potassium iodide, zinc oxide, choline bitartrate, with doconexent and icosapent kit
If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.
| NDC | |
|---|---|
| 1 | 50967-317-30 |
