Folcaps Omega-3 Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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.
There is currently no drug history available for this drug.
Folcaps™ Omega-3 is a prenatal/postnatal multivitamin/mineral capsule with omega-3 fatty acids.
Each red soft gelatin capsule for oral administration contains:
|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|
|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|
|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.