Foltabs 800

Midlothian Laboratories

Foltabs 800 Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

• FOLTABS 800 DESCRIPTION
• FOLTABS 800 INDICATIONS AND USAGE
• FOLTABS 800 CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • General
• FOLTABS 800 ADVERSE REACTIONS
• FOLTABS 800 DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• CONTAINER LABEL

FULL PRESCRIBING INFORMATION

FOLTABS 800 DESCRIPTION

Foltabs™ 800 is a scored green round multivitamin tablet. The tablet is debossed with “ML” on the scored side

and plain on the other.

Each tablet contains:

Vitamin B6 (Pyridoxine HCl) ................................................................. 10 mg

Folic Acid ...............................................................................................800 μg

Cyanocobalamin .....................................................................................115 μg

INACTIVE INGREDIENTS: Dicalcium Phosphate Dihydrate, Microcrystalline Cellulose, Stearic Acid, Silicon Dioxide, Croscarmellose Sodium, Magnesium Stearate, Polydextrose, Hypromellose, Polyethylene Glycol, Titanium Dioxide, D&C Yellow #10, Triacetin, FD&C Blue #1, FD&C Yellow #6

FOLTABS 800 INDICATIONS AND USAGE

Foltabs™ 800 is a multivitamin prescription supplement indicated for the use in improving the nutritional status of patients as prescribed by their physician.

FOLTABS 800 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.

KEEP 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 800 ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

FOLTABS 800 DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

HOW SUPPLIED

FOLCAPS Tablet is a round, green-coated bisected tablet debossed 'ML' on one side and plain on the other side.

Bottles of 60 tablets ................................. NDC 68308-325-60

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. 12/09

CONTAINER LABEL