Folcaps Care One description, usages, side effects, indications, overdosage, supplying and lots more!

Folcaps Care One

Midlothian Laboratories

Folcaps™ Care One

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Rx Only

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 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

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.

DOSAGE AND ADMINISTRATION

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

HOW 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

PRINCIPAL DISPLAY PANEL - 30 Capsule Label

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

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:68308-167
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
calcium ascorbate Ascorbic Acid 24 mg
calcium threonate Calcium cation 1 mg
CHOLECALCIFEROL CHOLECALCIFEROL 800 [iU]
ALPHA-TOCOPHEROL ACETATE ALPHA-TOCOPHEROL 15 [iU]
RIBOFLAVIN RIBOFLAVIN 1.5 mg
NIACINAMIDE 10 mg
PYRIDOXINE HYDROCHLORIDE PYRIDOXINE 50 mg
FOLIC ACID FOLIC ACID 1 mg
BIOTIN 300 mg
CALCIUM CARBONATE 100 mg
IRON IRON 27 mg
Iodine IODINE 150 ug
MAGNESIUM 50 mg
Zinc ZINC 5 mg
DOCUSATE SODIUM DOCUSATE 50 mg
DOCONEXENT DOCONEXENT 350 mg
ICOSAPENT ICOSAPENT 100 mg
LINOLENIC ACID 50 mg

Inactive Ingredients

Ingredient Name Strength
GELATIN
GLYCERIN
SOYBEAN OIL
FLAX SEED
ETHYL VANILLIN
LECITHIN, SOYBEAN
WAX, YELLOW
titanium dioxide
SILICON DIOXIDE
FD&C RED NO. 40

Product Characteristics

Color Size Imprint Code Shape
RED 25 mm ML;167 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68308-167-30 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2009-05-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.