FaBB Tablets

Midlothian Laboratories

FaBB Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

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

FULL PRESCRIBING INFORMATION

FABB TABLETS 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 B6 (Pyridoxine HCl) ................................................................ 25 mg

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

Cyanocobalamin ........................................................................................1 mg

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

FABB TABLETS INDICATIONS AND USAGE

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

FABB TABLETS 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.

FABB TABLETS ADVERSE REACTIONS

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

FABB TABLETS 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 '326' on the other side.

Bottles of 100 tablets ................................. NDC 68308-326-10

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