DESCRIPTION

CONTENTS:   Each blue soft gelatin capsule, imprinted images/77/36001501.jpg0331 contains:

Calcium (as calcium carbonate) ................................. 200 mg

Vitamin C (ascorbic acid) ............................................ 60 mg

Iron (as ferrous fumarate) ............................................ 28 mg

Docusate Calcium ....................................................... 25 mg

Vitamin E ( d -alpha tocopherol) ..................................... 30 IU

Vitamin B 6 (pyridoxine hydrochloride) ......................... 20 mg

Vitamin B 2 (riboflavin) ................................................ 1.8 mg

Vitamin B 1 (thiamine mononitrate) .............................. 1.6 mg

Folic Acid ..................................................................... 1 mg

Vitamin B 12 (cyanocobalamin) .................................. 12 mcg

Vitamin D (cholecalciferol) .........................................  400 IU

ACTIVE INGREDIENT:   Each gelcap contains 1 mg folic acid.

INDICATIONS

New Formulation Chromagen® OB is a vitamin and mineral nutritional supplement indicated for use in women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. It is also useful for improving the nutritional status of women prior to conception.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

Supplemental vitamins should also not be prescribed for patients with Wilson' disease.

WARNINGS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient.

WARNING:    Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Allergy Alert: These gelcaps contain a soy product.

Average gelcap doses in sensitive individuals or excessive dosage may cause nausea, skin rash, vomiting, diarrhea, precordial pain, or flushing of the face and extremities.

PRECAUTIONS

General:

Folic acid, in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

Information for Patients:

Patients should not exceed the recommended dosage unless directed by the physician. Patients should be informed that iron therapy can cause black or dark stools.

ADVERSE REACTIONS

The following adverse reactions, normally associated with iron products, such as New Formulation Chromagen® OB, may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions are usually transient.

USUAL ADULT DOSAGE

One soft gelatin capsule daily, to be taken with food and a full glass of water.

HOW SUPPLIED

NDC 0281-0331-53, bottle of 100 capsules.

Dispense in a tight, light resistant container with a child resistant closure.

Store at controlled room temperature 15°-30°C (59°-86°F).

Avoid excessive heat 40°C (104°F). Avoid freezing.

Manufactured for:

SAVAGE LABORATORIES®

a division of Altana Inc.

Melville, New York 11747

by: R.P. Scherer Corporation

St. Petersburg, Florida 33702                     R7/01



Copyright© 2002 Medical Economics