Folcaps Care One
Generic Name: prenatal multivitamin/mineral capsule with omega-3 fatty acids
Dosage Form: capsule, gelatin coated
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.
Folcaps™ Care One
Rx Only
Folcaps Care One Description
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 |
| Vitamins: | |
| 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 |
| Minerals: | |
| Calcium (carbonate, USP) | 100 mg |
| Iron (elemental) | |
| 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 |
| Other: | |
| 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.
INTENDED USE
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.
Contraindications
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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™ Care One should be used with caution in patients with known sensitivity or allergy to fish or soy.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
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.
Folcaps Care One Dosage and Administration
Usual dosage is one capsule daily, or as prescribed by a physician.
How is Folcaps Care One Supplied
Folcaps™ Care One prenatal multivitamin/mineral capsules are red soft gelatin capsules packaged in bottles of 30 capsules.
(NDC: 68308-167-30)
Store at controlled room temperature 15°-30° C (59°-86° F). [See USP controlled room temperature.]
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Manufactured for:
Midlothian Laboratories
Montgomery, AL 36117
Rev. 4/09
PRINCIPAL DISPLAY PANEL - 30 Capsule Label
NDC 68308-167-30
30 Capsules
Folcaps™
Care One
DESCRIPTION:
Folcaps™ Care One is a prenatal multivitamin/mineral
capsule with omega-3 fatty acids.
INACTIVE INGREDIENTS: Gelatin, glycerin, soybean oil,
flaxseed oil, ethylvanillin, lecithin, yellow beeswax, titanium
dioxide, silicon dioxide, and FD&C Red No. 40.
Rx Only
Midlothian
LABORATORIES
| Folcaps Care One calcium ascorbate, calcium threonate, cholecalciferol, alpha-tocopheryl acetate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, calcium carbonate, iron, iodine, magnesium, zinc, docusate sodium, doconexent, icosapent, and linolenic acid capsule, gelatin coated | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Labeler - Midlothian Laboratories (142122824) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Tishcon Corporation | 195342449 | MANUFACTURE | |
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