Label: FOLCAPS OMEGA-3- calcium ascorbate, calcium threonate, cholecalciferol, alpha-tocopherol acetate, folic acid, pyridoxine hydrochloride, calcium, iron, ferrous asparto glycinate, doconexent, icosapent and linolenic acid capsule, gelatin coated
- NDC Code(s): 68308-269-30
- Packager: Midlothian Laboratories
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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- BOXED WARNING(What is this?)
Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.Close
- SPL UNCLASSIFIED SECTION
Folcaps™ Omega-3 is a prenatal/postnatal multivitamin/mineral capsule with omega-3 fatty acids.
Each red soft gelatin capsule for oral administration contains:
- The Omega-3 fatty acids are derived from a refined fish oil concentrate and soybean oil.
Essential Fatty Acids: Omega-3 Fatty Acids* (DHA, EPA, and ALA) 330 mg Docohexaenoic Acid (DHA) 260 mg Eicosapentaenoic Acid (EPA) 40 mg Alpha-linolenic Acid (ALA) 30 mg Linoleic Acid 30 mg Vitamins: Vitamin C (as calcium ascorbate and calcium threonate) 25 mg Vitamin D3 (cholecalciferol) 170 IU Vitamin E (dl-alpha-tocopheryl acetate) 30 IU Folic Acid, USP 1 mg Vitamin B6 (pyridoxine hydrochloride) 25 mg Minerals: Calcium Iron (elemental) 150 mg Carbonyl iron 20 mg Ferrous Asparto Glycinate 7 mg
INACTIVE INGREDIENTS: Gelatin, glycerin, yellow beeswax, silicon dioxide, purified water, soy lecithin, titanium dioxide, FD&C Red #40, ethyl vanillin, and corn oil.Close
- INTENDED USE
Folcaps™ Omega-3 is intended to provide improved nutritional status before, during, and after pregnancy, through dietary supplementation of key vitamin/mineral and omega-3 fatty acids.Close
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.Close
Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anti-coagulants and in those known to have inherited or acquired bleeding diathesis.Close
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.Close
Do not exceed recommended dosage. Folcaps™ Omega-3 should be used with caution in patients with known sensitivity or allergy to fish or soy.
Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
- ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.Close
- DOSAGE AND ADMINISTRATION
Usual dosage is one capsule daily, or as prescribed by a physician.Close
- HOW SUPPLIED
Folcaps™ Omega-3 prenatal/postnatal multivitamin/mineral capsules are red soft gelatin, packaged in bottles of 30 capsules.
Store at controlled room temperature 15°-30° C (59°-86° F). [See USP controlled room temperature.]
THIS PRODUCT CONTAINS SOY.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
- PRINCIPAL DISPLAY PANEL - 30 Capsule Label
Folcaps™ Omega-3 is a prenatal/postnatal
multivitamin/mineral capsule with omega-3 fatty acids.
INACTIVE INGREDIENTS: Gelatin, glycerin, yellow beeswax,
silicon dioxide, purified water, soy lecithin, titanium dioxide,
FD&C Red #40, ethyl vanillin, and corn oil.
- INGREDIENTS AND APPEARANCE
calcium ascorbate, calcium threonate, cholecalciferol, alpha-tocopherol acetate, folic acid, pyridoxine hydrochloride, calcium, iron, ferrous asparto glycinate, doconexent, icosapent, and linolenic acid capsule, gelatin coated
Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68308-269 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM ASCORBATE (CALCIUM ASCORBATE) CALCIUM ASCORBATE 24 mg CALCIUM THREONATE (CALCIUM THREONATE) CALCIUM THREONATE 1 mg CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 170 [iU] ALPHA-TOCOPHEROL ACETATE (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL ACETATE 30 [iU] FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg CALCIUM (CALCIUM) CALCIUM 150 mg IRON (IRON) IRON 20 mg FERROUS ASPARTO GLYCINATE (FERROUS ASPARTO GLYCINATE) FERROUS ASPARTO GLYCINATE 7 mg DOCONEXENT (DOCONEXENT) DOCONEXENT 260 mg ICOSAPENT (ICOSAPENT) ICOSAPENT 40 mg LINOLENIC ACID (LINOLENIC ACID) LINOLENIC ACID 30 mg Inactive Ingredients Ingredient Name Strength GELATIN GLYCERIN YELLOW WAX SILICON DIOXIDE WATER LECITHIN, SOYBEAN TITANIUM DIOXIDE FD&C RED NO. 40 ETHYL VANILLIN CORN OIL Product Characteristics Color RED Score no score Shape CAPSULE Size 25mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68308-269-30 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/03/2011 Labeler - Midlothian Laboratories (142122824) Establishment Name Address ID/FEI Business Operations Tishcon Corporation 195342449 MANUFACTURE Establishment Name Address ID/FEI Business Operations Rainbow Gold Products, Inc. 800695152 REPACK