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 doctor or poison control center immediately.

FERO-FOLIC-500 Filmtab tablets are a hematinic for oral administration containing iron in the Gradumet controlled-release vehicle; Vitamin C for enhancement of iron absorption; and folic acid. Each tablet provides 525 mg of ferrous sulfate (equivalent to 105 mg of elemental iron), 800 mcg of folic acid and 500 mg of ascorbic acid present as sodium ascorbate.

Inactive Ingredients:   Castor oil, cellulosic polymers, D&C Red No. 30, magnesium stearate, methyl acrylate-methyl methacrylate copolymer, pregelatinized starch (contains corn starch), polyethylene glycol, povidone, propylene glycol, talc, titanium dioxide and vanillin.

IBERET-FOLIC-500 tablets are a hematinic for oral administration containing iron in the Gradumet® controlled-release vehicle; vitamin C for enhancement of iron absorption; and the B-Complex vitamins including folic acid.

Each Filmtab tablet provides:

*Ferrous Sulfate .............................................................. 525 mg
  (equivalent to 105 mg of elemental iron)

Ascorbic Acid (present as sodium ascorbate) (C) ............ 500 mg

Niacinamide  ..................................................................... 30 mg

Calcium Pantothenate  ....................................................... 10 mg

Thiamine Mononitrate (B 1 ) .................................................. 6 mg

Riboflavin (B 2 )  ................................................................... 6 mg

Pyridoxine Hydrochloride (B 6 ) ...........................................  5 mg

Folic Acid ..................................................................... 800 mcg

Cyanocobalamin (B 12 ) .................................................... 25 mcg

*In controlled-release form (Gradumet)

Filmtab®-Film--Film-sealed tablets, Abbott

Inactive Ingredients:   Castor oil, cellulosic polymers, corn starch, D&C Red No. 7, FD&C Blue No. 1, FD&C Blue No. 2, magnesium stearate, methyl acrylate-methyl methacrylate copolymer, polyethylene glycol, povidone, propylene glycol, stearic acid, talc, titanium dioxide and vanillin.

Controlled-release of iron from the Gradumet protects against gastric side effects. The Gradumet is an inert, porous, plastic matrix impregnated with ferrous sulfate. Iron is leached from the Gradumet as it passes through the gastrointestinal tract, and the expended matrix is excreted harmlessly in the stool. Controlled-release iron is particularly helpful in patients who have demonstrated intolerance to oral iron preparations.

Oral iron is absorbed most efficiently when administered between meals. Conventional iron preparations frequently cause gastric irritation when taken on an empty stomach. Studies with iron in the Gradumet have indicated that relatively little of the iron is released in the stomach, gastric intolerance is seldom encountered, and hematologic response ranks with that obtained from plain ferrous sulfate.

Iron is found in the body principally as hemoglobin. Storage in the form of ferritin occurs in the liver, spleen, and bone marrow. Concentrations of plasma iron and the total iron-binding capacity of plasma vary greatly in different physiological conditions and disease states.

Large amounts of ascorbic acid administered orally with ferrous sulfate have been shown to enhance iron absorption. Apparently this is due to the ability of ascorbic acid to prevent the oxidation of ferrous iron to the less effectively absorbed ferric form.

Folic acid and iron are absorbed in the proximal small intestine, particularly the duodenum. Folic acid is absorbed maximally and rapidly at this site, and iron is absorbed in a descending gradient from the duodenum distally.

After absorption folic acid is rapidly converted into its metabolically active forms. Approximately two-thirds is bound to plasma protein. Half of the folic acid stored in the body is found in the liver. Folic acid is also concentrated in spinal fluid.

Except for the folates ingested in liver, yeast, and egg yolk, the percentage of absorption of food folates averages about 10%.

The B-complex vitamins in IBERET-FOLIC-500 are absorbed by the active transport process. B-complex vitamins are rapidly eliminated and therefore are not stored in the body.

Calcium pantothenate is absorbed readily from the gastrointestinal tract and distributed to all body tissues.

FERO-FOLIC-500 is indicated for the treatment of iron deficiency and prevention of concomitant folic acid deficiency in non-pregnant adults. FERO-FOLIC-500 is also indicated in pregnancy for the prevention and treatment of iron deficiency and to supply a maintenance dosage of folic acid.

IBERET-FOLIC-500 is indicated in non-pregnant adults for the treatment of iron deficiency and prevention of concomitant folic acid deficiency with an associated deficient intake or increased need for the B-complex vitamins. IBERET-FOLIC-500 is also indicated in pregnancy for the prevention and treatment of iron deficiency with a concomitant deficient intake or increased need for the B-complex vitamins (including folic acid).

CONTRAINDICATIONS

FERO-FOLIC-500 and IBERET-FOLIC-500 are contraindicated in patients with pernicious anemia.

FERO-FOLIC-500 and IBERET-FOLIC-500 are also contraindicated in the rare instance of hypersensitivity to folic acid.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. See boxed WARNING regarding overdose in children.

PRECAUTIONS

Where anemia exists, its nature should be established and underlying causes determined.

FERO-FOLIC-500 and IBERET-FOLIC-500 contain 800 mcg of folic acid per tablet. Folic acid especially in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progresssive. Concomitant parenteral therapy with vitamin B 12 may be necessary in patients with deficiency of vitamin B 12 . Pernicious anemia is rare in women of childbearing age, and the likelihood of its occurrence along with pregnancy is reduced by the impairment of fertility associated with vitamin B 12 deficiency

Laboratory Tests:   In older patients and those with conditions tending to lead to vitamin B 12 depletion, serum B 12 levels should be regularly assessed during treatment with FERO-FOLIC-500 or IBERET-FOLIC-500.

Drug Interactions:    Absorption of iron is inhibited by magnesium trisilicate and antacids containing carbonates.

Ferrous sulfate may interfere with the absorption of tetracyclines.

The antiparkinsonism effects of levodopa may be reversed by pyridoxine.

Iron absorption is inhibited by the ingestion of eggs or milk.

Carcinogenesis:   Adequate data are not available on long-term potential for carcinogenesis in animals or humans.

Pregnancy:   Pregnancy Category A. Studies in pregnant women have not shown that FERO-FOLIC-500 or IBERET-FOLIC-500 increase the risk of fetal abnormalities if administered during pregnancy. If either of these drugs is used during pregnancy, the possibility of fetal harm appears remote. Because studies cannot rule out the possibility of harm, however, FERO-FOLIC-500 or IBERET-FOLIC-500 should be used during pregnancy only if clearly needed.

Nursing Mothers:   Folic acid, ascorbic acid, and B-complex vitamins are excreted in breast milk.

ADVERSE REACTIONS

The likelihood of gastric intolerance to iron in the controlled-release Gradumet vehicle is remote. If such should occur, the tablet may be taken after a meal. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

OVERDOSAGE

Signs of serious toxicity may be delayed because the iron is in a controlled-release dose form. Increased capillary permeability, reduced plasma volume, increased cardiac output, and sudden cardiovascular collapse may occur in acute iron intoxication. In overdosage, efforts should be made to hasten the elimination of the Gradumet tablets ingested. An emetic should be administered as soon as possible, followed by gastric lavage if indicated. Immediately following emesis, a large dose of a saline cathartic should be used to speed passage through the intestinal tract. X-ray examination may then be considered to determine the position and number of Gradumet tablets remaining in the gastrointestinal tract.

DOSAGE AND ADMINISTRATION

Adults, including Pregnant Females:  The recommended dose is one Fero-Folic-500 or one Iberet-Folic-500 tablet daily on an empty stomach.

HOW SUPPLIED

FERO-FOLIC-500 red Filmtab tablets, imprinted with the Abbott logo images/70/04020499.jpgand Abbo-Code identification letters AJ, are supplied in packages of 30 tablets ( NDC 0074-7079-30) each containing 5 child-resistant blisters of 6 tablets.

IBERET-FOLIC-500 red Filmtab tablets, imprinted with the Abbott logo images/70/04020499.jpgand Abbo-Code identification letters AK, are supplied in packaes of 30 tablets ( NDC 0074-7125-30) each containing 5 child-resistant blisters of 6 tablets.

FILMTAB--Film-sealed tablets, Abbott.

GRADUMET--Controlled-release dose form, Abbott.

Recommended Storage: below 77°F (25°C). Protect from light to avoid tablet color changes.

Ref. 13-1743-8/R1 and 13-1746-7/R1