Each chewable tablet contains calcium polycarbophil (equivalent to 500 mg polycarbophil, USP). The inactive ingredients present are aminoacetic acid, corn starch, D&C yellow 10 aluminum lake, flavors, magnesium stearate, mannitol, povidone, sucrose.

Actions:   Mitrolan (calcium polycarbophil) is a hydrophilic agent. As a bulk laxative, Mitrolan retains free water within the lumen of the intestine, and indirectly opposes dehydrating forces of the bowel, promoting well-formed stools. In diarrhea, when the intestinal mucosa is incapable of absorbing water at normal rates, Mitrolan absorbs free fecal water, forming a gel and producing formed stools. Thus, in both diarrhea and constipation, the drug works by restoring a more normal moisture level and providing bulk in the patient' intestinal tract.

  For the treatment of constipation or diarrhea associated with conditions such as irritable bowel syndrome and diverticulosis. Also for the treatment of acute non-specific diarrhea. Restores normal stool consistency by regulating its water and bulk content.

Contraindications:   As with all hydrophilic bulking agents, calcium polycarbophil should not be used in patients with signs of gastrointestinal obstruction.

:   As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

Adverse Reactions:   Abdominal fullness may be noted occasionally. An adjustment of the dosage schedule with smaller doses given more frequently but spaced evenly throughout the day may provide relief of this symptom during continued use of Mitrolan.

Drug Interaction:   Antacids containing aluminum, calcium or magnesium impair absorption of tetracycline. Although Mitrolan is not an antacid, it releases free calcium after ingestion and should not be used by any patient who is taking a prescription antibiotic drug containing any form of tetracycline.

Directions for Use:

CHEW TABLETS BEFORE SWALLOWING. Recommended dosage for OTC use: Adults--Chew and swallow 2 tablets 4 times a day, or as needed. Do not exceed 12 tablets in a 24-hour period. Children (6 to under 12 years)--Chew and swallow 1 tablet 3 times a day, or as needed. Do not exceed 6 tablets in a 24-hour period. Children (3 to under 6 years)--Chew and swallow 1 tablet 2 times a day, or as needed. Do not exceed 3 tablets in a 24-hour period. Children under 3 years: Consult a physician.

For episodes of severe diarrhea, the dose may be repeated every 1 / 2 hour, but do not exceed the maximum daily dosage.

Dosage may be adjused according to individual response.

When using as a laxative, patient should drink a full glass (8 fl. oz.) of water or other liquid with each dose.

Sodium Content:   Less than 0.02 mEq (0.46 mg) per tablet.

How Supplied:    Chewable Tablets --cartons of 36 individually packaged blister units (NDC 0031-1535-57) and bottles of 100 (NDC 0031-1535-63).

Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F).

Manufactured by:

Pharmaceutical Division

A.H. Robins Company

Richmond, Virginia 23220

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.