Foltabs Prenatal Plus DHA

prenatal vitamins and minerals

Dosage Form: tablets/capsules
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

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 NDC Product Code (Source) 68308-160

Packaging # NDC Package Description Multilevel Packaging 1 68308-160-30 1 BLISTER PACK In 1 KIT None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 0 BLISTER PACK   1  Part 2 0 BLISTER PACK   1

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 # NDC Package Description Multilevel Packaging 1 30 TABLET In 1 BLISTER PACK None

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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW (Amber) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code NONE Contains

Packaging # NDC Package Description Multilevel Packaging 1 30 CAPSULE In 1 BLISTER PACK None

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: 12/2009Midlothian Laboratories, LLC

More Foltabs Prenatal Plus DHA resources

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