Active Ingredients:    Dulcolax Tablets -Bisacodyl USP 5 mg.

Dulcolax Suppositories -Bisacodyl USP 10 mg.

Inactive Ingredients:   Dulcolax Tablets -acacia, acetylated monoglyceride, carnauba wax, cellulose acetate phthalate, corn starch, D&C Red No. 30 aluminum lake, D&C Yellow No. 10 aluminum lake, dibutyl phthalate, docusate sodium, gelatin, glycerin, iron oxides, kaolin, lactose, magnesium stearate, methylparaben, pharmaceutical glaze, polyethylene glycol, povidone, propylparaben, sodium benzoate, sorbitan monooleate, sucrose, talc, titanium dioxide, white wax. Dulcolax Suppositories -Hydrogenated vegetable oil.

Sodium Content: Tablets and suppositories contain less than 0.2 mg per dosage unit and are thus dietetically sodium free.

For the relief of occasional constipation and irregularity. Physicians should refer to the "Professional Labeling" section for additional indications and information.

Directions:

Tablets

Adults and children 12 years of age and over: Take 2 or 3 tablets (usually 2) in a single dose once daily.

Children 6 to under 12 years of age: Take 1 tablet once daily.

Children under 6 years of age: Consult a physician.

Expect results in 8-12 hours if taken at bedtime or within 6 hours if taken before breakfast.

Suppositories

Adults and children 12 years of age and over: 1 suppository once daily. Remove foil wrapper. Lie on your side and, with pointed end first, push suppository high into the rectum so it will not slip out. Retain it for 15 to 20 minutes. If you feel the suppository must come out immediately, it was not inserted high enough and should be pushed higher.

Children 6 to under 12 years of age: 1 / 2 suppository once daily.

Children under 6 years of age: Consult a physician.

If the suppository seems soft, hold in foil wrapper under cold water for one or two minutes before use. In the presence of anal fissures or hemorrhoids, suppository may be coated at the tip with petroleum jelly before insertion.

: Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a physician. If you have noticed a sudden change in bowel habits that persists over a period of 2 weeks, consult a physician before using a laxative. Restoration of normal bowel function by using this product may cause abdominal discomfort including cramps. Laxative products should not be used for a period longer than 1 week unless directed by a physician. Rectal bleeding or failure to have a bowel movement after use of a laxative may indicate a serious condition. If this occurs, discontinue use and consult your physician. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product. Keep this and all drugs out of the reach of children. In case of accidental overdose or ingestion, seek professional assistance or contact a poison control center immediately.

For tablets: Do not chew or crush. Do not give to children under 6 years of age unless directed by a physician. Do not take this product within 1 hour after taking an antacid or milk.

How Supplied: Dulcolax, brand of bisacodyl: Yellow, enteric-coated tablets of 5 mg in boxes of 10, 25, 50 and 100; suppositories of 10 mg in boxes of 4, 8, 16 and 50.

Store Dulcolax suppositories and tablets at temperatures below 77°F (25°C). Avoid excessive humidity.

Also Available:   Dulcolax® Bowel Prep Kit. Each kit contains:

1 Dulcolax suppository of 10 mg bisacodyl;

4 Dulcolax tablets of 5 mg bisacodyl;

Complete patient instructions.

Professional Labeling

and Clinical Pharmacology: Dulcolax is a contact stimulant laxative, administered either orally or rectally, which acts directly on the colonic mucosa to produce normal peristalsis throughout the large intestine. The active ingredient in Dulcolax, bisacodyl, is a colorless, tasteless compound that is practically insoluble in water or alkaline solution. Its chemical name is: bis(p-acetoxyphenyl)-2-pyridylmethane. Bisacodyl is very poorly absorbed, if at all, in the small intestine following oral administration, nor in the large intestine following rectal administration. On contact with the mucosa or submucosal plexi of the large intestine, bisacodyl stimulates sensory nerve endings to produce parasympathetic reflexes resulting in increased peristaltic contractions of the colon. It has also been shown to promote fluid and ion accumulation in the colon, which increases the laxative effect. A bowel movement is usually produced approximately 6 hours after oral administration (8-12 hours if taken at bedtime), and approximately 15 minutes to 1 hour after rectal administration, providing satisfactory cleansing of the bowel which may, under certain circumstances, obviate the need for colonic irrigation.

and Usage: For use as part of a bowel cleansing regimen in preparing the patient for surgery or for preparing the colon for x-ray endoscopic examination. Dulcolax will not replace the colonic irrigations usually given patients before intracolonic surgery, but is useful in the preliminary emptying of the colon prior to these procedures.

Also for use as a laxative in postoperative care (i.e., restoration of normal bowel hygiene), antepartum care, postpartum care, and in preparation for delivery.

Contraindications: Stimulant laxatives, such as Dulcolax, are contraindicated for patients with acute surgical abdomen, appendicitis, rectal bleeding, gastroenteritis, or intestinal obstruction.

Precautions: Long-term administration of Dulcolax is not recommended in the treatment of chronic constipation.

Dosage and Administration:

Preparation for x-ray endoscopy: For barium enemas, no food should be given following oral administration to prevent reaccumulation of material in the cecum, and a suppository should be administered one to two hours prior to examination.

Children under 6 years of age: Oral administration is not recommended due to the requirement to swallow tablets whole. For rectal administration, the suppository dosage is 5 mg ( 1 / 2 of 10 mg suppository) in a single daily dose.