Folcaps Care One 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™ Care One 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™ Care One is a prenatal 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)||500 mg|
|Docosahexaenoic Acid (DHA)||350 mg|
|Eicosapentaenoic Acid (EPA)||100 mg|
|Alpha-linolenic Acid (ALA)||50 mg|
|Vitamin C (calcium ascorbate, USP and calcium threonate)||25 mg|
|Vitamin D3 (cholecalciferol, USP)||800 IU|
|Vitamin E (dl-alpha-tocopheryl acetate, USP)||15 IU|
|Vitamin B2 (riboflavin, USP)||1.5 mg|
|Vitamin B3 (niacinamide, USP)||10 mg|
|Vitamin B6 (pyridoxine hydrochloride, USP)||50 mg|
|Folic Acid, USP||1 mg|
|Biotin, USP||300 mcg|
|Calcium (carbonate, USP)||100 mg|
|Carbonyl iron, FCC||20 mg|
|Ferrous aspartate and ferrous glycinate||7 mg|
|Iodine (potassium iodide, USP)||150 mcg|
|Magnesium (magnesium oxide, USP)||50 mg|
|Zinc (zinc oxide, USP)||5 mg|
|Docusate Sodium, USP||50 mg|
INACTIVE INGREDIENTS: Gelatin, glycerin, soybean oil, flaxseed oil, ethylvanillin, lecithin, yellow beeswax, titanium dioxide, silicon dioxide, and FD&C Red No. 40.