Your browser does not support JavaScript! FOLCAPS OMEGA-3 (CALCIUM ASCORBATE, CALCIUM THREONATE, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CALCIUM, IRON, FERROUS ASPARTO GLYCINATE, DOCONEXENT, ICOSAPENT, AND LINOLENIC ACID) CAPSULE, GELATIN COATED [MIDLOTHIAN LABORATORIES]
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FOLCAPS OMEGA-3 (calcium ascorbate, calcium threonate, cholecalciferol, alpha-tocopherol acetate, folic acid, pyridoxine hydrochloride, calcium, iron, ferrous asparto glycinate, doconexent, icosapent, and linolenic acid) capsule, gelatin coated
[Midlothian Laboratories]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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.

Rx Only

DESCRIPTION

Folcaps™ Omega-3 is a prenatal/postnatal 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)330 mg
    Docohexaenoic Acid (DHA)260 mg
    Eicosapentaenoic Acid (EPA)40 mg
    Alpha-linolenic Acid (ALA)30 mg
  Linoleic Acid30 mg
  
Vitamins:
  Vitamin C (as calcium ascorbate and calcium threonate)25 mg
  Vitamin D3 (cholecalciferol)170 IU
  Vitamin E (dl-alpha-tocopheryl acetate)30 IU
  Folic Acid, USP1 mg
  Vitamin B6 (pyridoxine hydrochloride)25 mg
  
Minerals:
Calcium Iron (elemental)150 mg
  Carbonyl iron20 mg
  Ferrous Asparto Glycinate7 mg

INACTIVE INGREDIENTS: Gelatin, glycerin, yellow beeswax, silicon dioxide, purified water, soy lecithin, titanium dioxide, FD&C Red #40, ethyl vanillin, and corn oil.

INTENDED USE

Folcaps™ Omega-3 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™ Omega-3 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™ Omega-3 prenatal/postnatal multivitamin/mineral capsules are red soft gelatin, packaged in bottles of 30 capsules.
(NDC: 68308-269-30)

Store at controlled room temperature 15°-30° C (59°-86° F). [See USP controlled room temperature.]

THIS PRODUCT CONTAINS SOY.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL - 30 Capsule Label

NDC 68308-269-30
30 Capsules

Folcaps™
Omega 3

DESCRIPTION:
Folcaps™ Omega-3 is a prenatal/postnatal
multivitamin/mineral capsule with omega-3 fatty acids.

INACTIVE INGREDIENTS: Gelatin, glycerin, yellow beeswax,
silicon dioxide, purified water, soy lecithin, titanium dioxide,
FD&C Red #40, ethyl vanillin, and corn oil.

Rx Only

Midlothian
LABORATORIES

PRINCIPAL DISPLAY PANEL - 30 Capsule Label
FOLCAPS OMEGA-3 
calcium ascorbate, calcium threonate, cholecalciferol, alpha-tocopherol acetate, folic acid, pyridoxine hydrochloride, calcium, iron, ferrous asparto glycinate, doconexent, icosapent, and linolenic acid capsule, gelatin coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68308-269
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM ASCORBATE (CALCIUM ASCORBATE) CALCIUM ASCORBATE24 mg
CALCIUM THREONATE (CALCIUM THREONATE) CALCIUM THREONATE1 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL170 [iU]
ALPHA-TOCOPHEROL ACETATE (ALPHA-TOCOPHEROL) ALPHA-TOCOPHEROL ACETATE30 [iU]
FOLIC ACID (FOLIC ACID) FOLIC ACID1 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE25 mg
CALCIUM (CALCIUM) CALCIUM150 mg
IRON (IRON) IRON20 mg
FERROUS ASPARTO GLYCINATE (FERROUS ASPARTO GLYCINATE) FERROUS ASPARTO GLYCINATE7 mg
DOCONEXENT (DOCONEXENT) DOCONEXENT260 mg
ICOSAPENT (ICOSAPENT) ICOSAPENT40 mg
LINOLENIC ACID (LINOLENIC ACID) LINOLENIC ACID30 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
YELLOW WAX 
SILICON DIOXIDE 
WATER 
LECITHIN, SOYBEAN 
TITANIUM DIOXIDE 
FD&C RED NO. 40 
ETHYL VANILLIN 
CORN OIL 
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize25mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68308-269-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/03/2011
Labeler - Midlothian Laboratories (142122824)
Establishment
NameAddressID/FEIBusiness Operations
Tishcon Corporation195342449MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Rainbow Gold Products, Inc.800695152REPACK

Revised: 1/2011
 
Midlothian Laboratories

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