Description

Colace (docusate sodium) is a stool softener.

Colace Capsules, 50 mg, contain the following:

Active Ingredient:   contains 50 mg of docusate sodium.

Inactive Ingredients:   Polyethylene glycol 400, gelatin, glycerin, sorbitol, propylene glycol, FD&C Red No. 40, D&C Red No. 33.

Colace Capsules, 100 mg, contain the following:

Active Ingredient:   contains 100 mg of docusate sodium.

Inactive Ingredients:   Polyethylene glycol 400, gelatin, glycerin, sorbitol, propylene glycol, methylparaben, titanium dioxide, FD&C Red No. 40, D&C Red No. 33, propylparaben, FD&C Yellow No. 6.

Colace Liquid, 1%, contains the following:

Active Ingredient:   each mL contains 10 mg of docusate sodium.

Inactive Ingredients:   citric acid, D&C Red No. 33, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, sodium citrate, vanillin, and purified water.

Colace Syrup, 20 mg/5 mL, contains the following:

Active Ingredient:   each 5 mL contains 20 mg of docusate sodium.

Inactive Ingredients:    alcohol (not more than 1%), citric acid, D&C Red No. 33, FD&C Red No. 40, flavor (natural), menthol, methylparaben, peppermint oil, poloxamer, polyethylene glycol, propylparaben, sodium citrate, sucrose, and purified water.

ACTIONS AND USES

Colace, a surface-active agent, helps to keep stools soft for easy, natural passage and is not a stimulant laxative, thus, not habit forming. Useful in constipation due to hard stools, in painful anorectal conditions, in cardiac and other conditions in which maximum ease of passage is desirable to avoid difficult or painful defecation, and when peristaltic stimulants are contraindicated.

Note: When peristaltic stimulation is needed due to inadequate bowel motility, see Peri-Colace (stimulant laxative and stool softener).

Contraindications

There are no known contraindications to Colace.

Warnings

Do not use when abdominal pain, nausea, or vomiting are present, unless directed by a doctor.

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. Bitter taste, throat irritation, and nausea (primarily associated with the use of the syrup and liquid) are the main side effects reported. Rash has occurred.

ADMINISTRATION AND DOSAGE

Orally  --Suggested daily Dosage: Adults and older children: 50 to 200 mg Children 6 to 12: 40 to 120 mg Liquid.

Infants and children under 3 years of age:   As prescribed by physician.

Children 3 to 6 years of age:   2mL one to three times daily

For retention or flushing enemas:   Add 5 to 10mL (1 to 2 tsp) of COLACE liquid to the enema fluid.

The higher doses are recommended for initial therapy. Dosage should be adjusted to individual response. The effect on stools is usually apparent 1 to 3 days after the first dose. Colace liquid or syrup must be given in a 6 oz. to 8 oz. glass of milk or fruit juice or in infant's formula to prevent throat irritation. In enemas-- Add 5 to 10 mL Colace liquid) to a retention or flushing enema.

How Supplied

Colace capsules, 50 mg

NDC 54092-052-30 Bottles of 30

NDC 54092-052-60 Bottles of 60

NDC 54092-052-52 Cartons of 100

  single unit packs

NDC 54092-052-11 Blister Pack of 10

Colace capsules, 100 mg

NDC 54092-053-30 Bottles of 30

NDC 54092-053-60 Bottles of 60

NDC 54092-053-02 Bottles of 250

NDC 54092-053-10 Bottles of 1000

NDC 54092-053-52 Cartons of 100

  single unit packs

NDC 54092-053-11 Blister Pack of 10

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

Colace liquid, 1% solution; 10 mg/mL (with calibrated dropper)

NDC 54092-414-16 Bottles of 16 fl oz

NDC 54092-414-30 Bottles of 30 mL

Colace syrup, 20 mg/5-mL teaspoon; contains not more than 1% alcohol

NDC 54092-415-08 Bottles of 8 fl oz

NDC 54092-415-16 Bottles of 16 fl oz

Manufactured for

Shire US Inc

Florence, KY 41042, USA