Foltabs Prenatal Plus DHA

Generic Name: prenatal vitamins and minerals
Dosage Form: tablets/capsules

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.

Foltabs Prenatal Plus DHA

Foltabs Prenatal Plus DHA Description

Foltabs™ Prenatal Plus DHA is a prescription prenatal/postnatal

multivitamin/mineral tablet and a gel capsule of an essential fatty acid. The prenatal

vitamin is a scored, white, oval multivitamin/mineral tablet. The tablet is debossed “ML

160” on one side and is blank on the other. The essential fatty acid DHA capsule is clear

and contains a light yellow semi-solid mixture.

Each prenatal tablet contains:

Vitamin C (Ascorbic acid) ................................................................... 120 mg

Calcium (Calcium citrate) ................................................................... 125 mg

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

Iron (Carbonyl iron, Ferrous gluconate) ............................................... 27 mg

Vitamin D3 (Cholecalciferol) ................................................................ 400 IU

Vitamin E (dl-alpha tocopheryl acetate) ................................................. 30 IU

Thiamin (Vitamin B1) ............................................................................. 3 mg

Riboflavin (Vitamin B2) ....................................................................... 3.4 mg

Niacinamide (Vitamin B3) .................................................................... 20 mg

Vitamin B6 (Pyridoxine HCl) ................................................................ 20 mg

Folic Acid ............................................................................................... 1 mg

Iodine (Potassium iodide) ................................................................. 150 mcg

Zinc (Zinc oxide) .................................................................................. 25 mg

Copper (Cupric sulfate) .......................................................................... 2 mg

Docusate Sodium ................................................................................. 50 mg

 

Each DHA gelatin capsule contains:

Docosahexaenoic Acid (DHA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250 mg

DHA is contained in the oil derived from a purified fish oil source.

Inactive Ingredients:

 Microcrystalline cellulose, croscarmellose sodium,

silicon dioxide, magnesium stearate, polysorbate 80, stearic acid, talc,

povidone, polyethylene glycol, titanium dioxide, polyvinyl alcohol.

Other ingredients in DHA gelatin capsule: Gelatin, Glycerin USP, Water.

Indications and Usage for Foltabs Prenatal Plus DHA

Foltabs™ Prenatal Plus DHA is a multivitamin/mineral prescription drug

indicated for use in improving the nutritional status of women prior to conception, throughout

pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

Contraindications

This product is contraindicated in patients with a known

hypersensitivity to any of the ingredients.

Warnings

 Accidental overdose of iron-containing products is a leading cause of fatal

poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.

In case of accidental overdose, call a doctor or poison control center immediately.

 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 anticoagulants

and in those known to have an inherited or acquired bleeding diathesis.

Folic acid alone is improper therapy in the treatment of pernicious anemia and

other megaloblastic anemias where vitamin B12 is deficient.

Precautions

Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in

that hematologic remission can occur while neurological manifestations progress.

 Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

NOTICE: Contact with moisture can discolor or erode the tablet.

Adverse Reactions

Allergic sensitization has been reported following both oral and

parenteral administration of folic acid. Caution should be exercised with patients with

known allergies to fish or fish byproducts.

Foltabs Prenatal Plus DHA Dosage and Administration

One tablet and one capsule daily or as directed by a physician.

How is Foltabs Prenatal Plus DHA Supplied

Six child-resistant blister packs of 5

tablets and 5 capsules each - NDC 68308-160-30.

Store at controlled room temperature.

Manufactured for:

Midlothian Laboratories, LLC

Montgomery, AL 36117

Rev 12/09

PRINCIPAL DISPLAY PANEL

Principal Display Panel

Foltabs Prenatal Plus DHA 
prenatal vitamins and minerals kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68308-160
Packaging
# Item Code Package Description
1 NDC:68308-160-30 1 KIT (BLISTER PACK) in 1 KIT
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 0 BLISTER PACK
Part 2 0 BLISTER PACK
Part 1 of 2
FOLTABS PRENATAL TABLETS 
prenatal vitamins and mineral tablets tablet, coated
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM IODIDE (POTASSIUM CATION) POTASSIUM IODIDE 150 ug
IRON PENTACARBONYL (IRON) IRON PENTACARBONYL 14 mg
FERROUS GLUCONATE (IRON) FERROUS GLUCONATE 13 mg
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg
THIAMINE MONONITRATE (THIAMINE) THIAMINE MONONITRATE 3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3.4 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 20 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
ZINC OXIDE (ZINC) ZINC OXIDE 25 mg
CUPRIC OXIDE (COPPER) CUPRIC OXIDE 2 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
CALCIUM CITRATE (CALCIUM) CALCIUM CITRATE 125 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
.ALPHA.-TOCOPHEROL ACETATE, D- (TOCOPHERSOLAN) .ALPHA.-TOCOPHEROL ACETATE, D- 30 [iU]
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 3350 1 mg
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (Modified Oval) Size 18mm
Flavor Imprint Code ML;160
Contains         
Packaging
# Item Code Package Description
1 30 TABLET, COATED (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/2009
Part 2 of 2
DHA CAPSULES 
docosahexaenoic acid capsule, liquid filled
Product Information
     
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCONEXENT (DOCONEXENT) DOCONEXENT 250 mg
Product Characteristics
Color YELLOW (Amber) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code NONE
Contains         
Packaging
# Item Code Package Description
1 30 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/2009
Labeler - Midlothian Laboratories, LLC (142122824)
Revised: 12/2009
 
Midlothian Laboratories, LLC
Hide
(web4)