Peri-Colace® is a combination of the mild stimulant laxative casanthranol, and the stool-softener Colace® (docusate sodium). Each capsule contains 30 mg of casanthranol and 100 mg of Colace®; the syrup contains 30 mg of casanthranol and 60 mg of Colace® per 15-mL tablespoon (10 mg of casanthranol and 20 mg of Colace® per 5-mL teaspoon) and 10% alcohol.

Peri-Colace® Capsules contain the following inactive ingredients: Polyethylene glycol 400, gelatin, glycerin, sorbitol, propylene glycol, titanium dioxide, methylparaben, FD&C Red No. 40, propylparaben, FD&C Blue No. 1.

Peri-Colace® Syrup contains the following inactive ingredients: alcohol (10% v/v), citric acid, flavors, methyl salicylate, methylparaben, poloxamer, polyethylene glycol, propylparaben, sodium citrate, sorbitol solution, sucrose, and purified water.

ACTION AND USES

Peri-Colace® provides gentle peristaltic stimulation and helps to keep stools soft for easier passage. Bowel movement is induced gently--usually overnight or in 8 to 12 hours. Nausea, griping, abnormally loose stools, and constipation rebound are minimized. Useful in management of chronic or temporary constipation.

Note:   To prevent hard stools when laxative stimulation is not needed or undesirable, see Colace® (stool softener).

Do not use when abdominal pain, nausea, or vomiting are present, unless directed by a doctor. Frequent or prolonged use of this preparation may result in dependence on laxatives.

As with any drug, pregnant or nursing women should seek the advice of a health professional before using this product.

SIDE EFFECTS

The incidence of side effects--none of a serious nature--is exceedingly small. Nausea, abdominal cramping or discomfort, diarrhea, and rash are the main side effects reported.

ADMINISTRATION AND DOSAGE

Adults  --1 or 2 capsules, or 1 or 2 tablespoons syrup at bedtime, or as indicated. In severe cases, dosage may be increased to 2 capsules or 2 tablespoons twice daily, or 3 capsules at bedtime. Children  --1 to 3 teaspoons of syrup at bedtime, or as indicated. Peri-Colace® syrup must be given in a 6 oz. to 8 oz. glass of milk or fruit juice or in infant' formula to prevent throat irritation.

OVERDOSAGE

In addition to symptomatic treatment, gastric lavage, if timely, is recommended in cases of large overdosage.

HOW SUPPLIED

Peri-Colace® Capsules

NDC 54092-054-30 Bottles of 30

NDC 54092-054-60 Bottles of 60

NDC 54092-054-02 Bottles of 250

NDC 54092-054-10 Bottles of 1000

NDC 54092-054-52 Cartons of 100 single unit packs

Note:   Peri-Colace® capsules should be stored at controlled room temperatures (59°-86°F or 15°-30°C).

Peri-Colace® Syrup

NDC 54092-418-08 Bottles of 8 fl oz

NDC 54092-418-16 Bottles of 16 fl oz

Peri-Colace®

NDC 54092-054-11 Blister Pack of 10

Manufactured for:

Roberts Laboratories Inc., a subsidiary of

ROBERTS PHARMACEUTICAL CORPORATION

Eatontown, NJ 07724 USA