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Folcaps Care One (calcium ascorbate 24 mg calcium threonate 1 mg cholecalciferol 800 [iu] alpha-tocopherol acetate 15 [iu] riboflavin 1.5 mg niacinamide 10 mg pyridoxine hydrochloride 50 mg folic acid 1 mg biotin 300 mg calcium carbonate 100 mg iron 27 mg iodine 150 ug magnesium 50 mg zinc 5 mg docusate sodium 50 mg doconexent 350 mg icosapent 100 mg linolenic acid 50 mg) Dailymed



IMPRINT: ML 167     SHAPE: capsule
    COLOR: red

Boxed Warning

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.

Boxed Warning

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.

Boxed Warning

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.


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Description


Folcapsâ„¢ 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 The Omega-3 fatty acids are derived from a refined fish oil concentrate and soybean oil. (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


Folcapsâ„¢ 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.

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. Folcapsâ„¢ 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.

Dosage And Administration


Usual dosage is one capsule daily, or as prescribed by a physician.

How Supplied


Folcapsâ„¢ Care One prenatal multivitamin/mineral capsules are red soft gelatin capsules packaged in bottles of 30 capsules.(NDC: 68308-167-30)

STORAGE AND HANDLING SECTION


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 LaboratoriesMontgomery, AL 36117

Rev. 4/09

Principal Display Panel - 30 Capsule Label


NDC 68308-167-30 30 Capsules

Folcapsâ„¢ Care One

DESCRIPTION: Folcapsâ„¢ Care One is a prenatal multivitamin/mineralcapsule with omega-3 fatty acids.

INACTIVE INGREDIENTS: Gelatin, glycerin, soybean oil,flaxseed oil, ethylvanillin, lecithin, yellow beeswax, titaniumdioxide, silicon dioxide, and FD&C Red No. 40.

Rx Only

Midlothian LABORATORIES

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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