Foltabs Prenatal

FOLTABS PRENATAL- potassium iodide, iron pentacarbonyl, ferrous gluconate, docusate sodium, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, zinc oxide, cupric oxide, ascorbic acid, calcium citrate, niacinamide, .alpha.-tocopherol acetate, dl- and cholecalciferol tablet
Midlothian Laboratories

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.

DESCRIPTION

Foltabs™ Prenatal is a scored white oval multivitamin/

multimineral tablet. The tablet is debossed with “ML 160” on the scored side

and plain on the other.

Each 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

INACTIVE INGREDIENTS: Microcrystalline cellulose, croscarmellose sodium,

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

povidone, polyethylene glycol, titanium dioxide, polyvinyl alcohol.

INDICATIONS AND USAGE

Foltabs™ Prenatal is a multivitamin/multimineral prescription

drug indicated for the 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

Folic acid alone is improper therapy in the treatment of pernicious

anemia and other megaloblastic anemias where vitamin B12 is deficient.

WARNING: Accidental overdose of iron-containing products is a leading cause

of fatal poisoning in children under the age of 6. KEEP THIS PRODUCT OUT OF

THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or

poison control center immediately.

PRECAUTIONS

General

NOTICE: Contact with moisture can produce surface discoloration or erosion of

the tablet.

Folic acid in doses above 0.1 mg may obscure pernicious

anemia in that hematologic remission can occur while neurological

manifestations progress.

ADVERSE REACTIONS

Allergic sensitization has been reported following both

oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

HOW SUPPLIED

FOLTABS Prenatal Tablet is a white-coated, speckled core tablet in modified oval shape, scored and debossed ‘ML160′ on one side and plain on the other side.

Bottles of 90 tablets …………………………… NDC 68308-165-90

DISPENSE IN A TIGHT, LIGHT RESISTANT CONTAINER AS DEFINED BY THE

USP/NF WITH A CHILD RESISTANT CLOSURE. Store at controlled room

temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C

(59°-86°F). [See current USP].

Manufactured for:

Midlothian Laboratories

Montgomery, AL 36117

www.midlothianlabs.com

Rev. 4/09

CONTAINER LABEL

FOLTABS PRENATAL TABLETS CONTAINER LABEL
(click image for full-size original)

FOLTABS CONTAINER LABEL

FOLTABS PRENATAL
prenatal vitamins and minerals tablets tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68308-165
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 30 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, DL- (ALPHA-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 30 [iU]
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
Product Characteristics
Color WHITE (White) Score 2 pieces
Shape OVAL (Modified Oval) Size 18mm
Flavor Imprint Code ML;160
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68308-165-90 90 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 01/01/2009
Labeler — Midlothian Laboratories (142122824)

Revised: 11/2009 Midlothian Laboratories

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