Folcaps

Midlothian Laboratories

Folcaps Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

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

FULL PRESCRIBING INFORMATION

FOLCAPS DESCRIPTION

Folcaps™ is a scored red round multivitamin tablet.

Each tablet contains:

Vitamin B6 (Pyridoxine HCl) ................................................................ 25 mg

Folic Acid ................................................................................................. 2.2 mg

Cyanocobalamin ....................................................................................500 μg

INACTIVE INGREDIENTS: Dicalcium Phosphate Dihydrate, Microcrystalline Cellulose, Stearic Acid, Silicon Dioxide, Croscarmellose Sodium, Magnesium Stearate

FOLCAPS INDICATIONS AND USAGE

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

FOLCAPS 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.

FOLCAPS ADVERSE REACTIONS

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

FOLCAPS DOSAGE AND ADMINISTRATION

One tablet daily or as directed by a physician.

HOW SUPPLIED

FOLCAPS Tablet is a round, pink-coated tablet debossed 'ML' on one side and '324' on the other side.

Bottles of 100 tablets ................................. NDC 68308-324-10

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