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
Mayne Pharma Inc.
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.
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Folcaps™ Omega-3
DESCRIPTION
Folcaps™ Omega-3 is a prenatal/postnatal multivitamin/mineral capsule with omega-3 fatty acids.
Each red soft gelatin capsule for oral administration contains:
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| 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.
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.
CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNING
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.
WARNING
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.
WARNING
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.
PRECAUTIONS
General
Do not exceed recommended dosage. Folcaps™ Omega-3 should be used with caution in patients with known sensitivity or allergy to fish or soy.
Geriatric Use
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.
HOW SUPPLIED
Folcaps™ Omega-3 prenatal/postnatal multivitamin/mineral capsules are red soft gelatin, packaged in bottles of 30 capsules.
(NDC: 68308-269-30)
PRINCIPAL DISPLAY PANEL - 30 Capsule Label
NDC 68308-269-30
30 Capsules
Folcaps™
Omega 3
DESCRIPTION:
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.
Rx Only
Midlothian
LABORATORIES
| 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 |
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| Labeler - Mayne Pharma Inc. (867220261) |