Foltabs Prenatal

Midlothian Laboratories

Foltabs Prenatal Tablet

FULL PRESCRIBING INFORMATION: CONTENTS*

• FOLTABS PRENATAL DESCRIPTION
• FOLTABS PRENATAL INDICATIONS AND USAGE
• FOLTABS PRENATAL CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
• FOLTABS PRENATAL ADVERSE REACTIONS
• FOLTABS PRENATAL DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• CONTAINER LABEL

FULL PRESCRIBING INFORMATION

FOLTABS PRENATAL 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.

FOLTABS PRENATAL 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.

FOLTABS PRENATAL 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.

FOLTABS PRENATAL ADVERSE REACTIONS

Allergic sensitization has been reported following both

oral and parenteral administration of folic acid.

FOLTABS PRENATAL 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