CONTENTS:   Each blue soft gelatin capsule, imprinted 0331 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.

DISCUSSION:   The amount of elemental iron and the absorption of the iron components of commercial iron preparations vary widely. Certain accessory components enhance absorption and utilization of iron. Chromagen® OB gelcaps are formulated to provide the essential factors for a complete, versatile vitamin and mineral supplement.

ACTIONS

HIGH ELEMENTAL IRON CONTENT:   Ferrous fumarate, used in Chromagen® OB gelcaps, is an organic iron complex which has the highest elemental iron content of any hematinic salt--33%. This compares with 20% for ferrous sulfate (heptahydrate) and 13% for ferrous gluconate.

MORE COMPLETE ABSORPTION:   It has been shown that ascorbic acid, when given in sufficient amounts, can increase the absorption of ferrous iron from the gastrointestinal tract. The effect of ascorbic acid may be related both to its reducing effect, preventing the formation of insoluble ferric hydroxide, and to its ability to form soluble complexes with ferric iron, which preserve the iron solubility at the more alkaline duodenal pH. Studies indicate that 60 mg of ascorbic acid can increase iron absorption. EachChromagen® OB gelcap contains 60 mg of ascorbic acid.

PROMOTES MOVEMENT OF PLASMA IRON:   Ascorbic acid also plays a role in the movement of plasma iron to storage depots in the tissues. The action, which leads to the transport of plasma iron to ferritin, presumably involves its reducing effect, converting transferrin iron from the ferric to the ferrous state. There is also evidence that ascorbic acid improves iron utilization, presumably as a further result of its reducing action. It may also have a direct effect upon erythropoiesis. Ascorbic acid is further alleged to enhance the conversion of folic acid to a more physiologically active form, folinic acid, necessary for erythropoiesis.

EXCELLENT ORAL TOLERATION:   Ferrous fumarate is used in Chromagen® OB gelcaps because it is less likely to cause gastric disturbances. Ferrous fumarate has a low ionization constant and high solubility in the entire pH range of the gastrointestinal tract. It does not precipitate proteins or have the astringency of ionizable forms of iron, and does not interfere with proteolytic or diastatic activities of the digestive system.

TOXICITY:   Ferrous fumarate is the least toxic of three popular iron salts.

INDICATIONS

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.

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

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 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      IF70331A

by: R.P. Scherer Corporation                       #242

St. Petersburg, Florida 33702                     R6/00

PRODUCT PHOTO(S):