Folcaps Care One

prenatal multivitamin/mineral capsule with omega-3 fatty acids

Dosage Form: capsule, gelatin coated
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:

* The Omega-3 fatty acids are derived from a refined fish oil concentrate and soybean oil.
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.

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. 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

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68308-167 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength calcium ascorbate (calcium ascorbate) calcium ascorbate 24 mg calcium threonate (calcium threonate) calcium threonate 1 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 800 [iU] ALPHA-TOCOPHEROL ACETATE (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL ACETATE 15 [iU] RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.5 mg NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 10 mg PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 50 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg BIOTIN (BIOTIN) BIOTIN 300 mg CALCIUM CARBONATE (CALCIUM) CALCIUM CARBONATE 100 mg IRON (IRON) IRON 27 mg IODINE (POTASSIUM CATION) IODINE 150 ug MAGNESIUM (MAGNESIUM OXIDE) MAGNESIUM 50 mg ZINC (ZINC OXIDE) ZINC 5 mg DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg DOCONEXENT (DOCONEXENT) DOCONEXENT 350 mg ICOSAPENT (ICOSAPENT) ICOSAPENT 100 mg LINOLENIC ACID (LINOLENIC ACID) 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 RED Score no score Shape CAPSULE Size 25mm Flavor Imprint Code ML;167 Contains

Packaging # NDC Package Description Multilevel Packaging 1 68308-167-30 30 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		05/01/2009

Labeler - Midlothian Laboratories (142122824)

Establishment
Name	Address	ID/FEI	Operations
Tishcon Corporation		195342449	MANUFACTURE

Revised: 12/2009Midlothian Laboratories

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