Docusate Sodium

Cardinal Health

Docusate Sodium Liquid 100 mg/10 ml

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Keep Out of Reach of Children
• Docusate Sodium Uses
• Warnings
• Directions
• Inactive ingredients
• Indications
• Drug Interaction Precaution
• How Supplied
• Storage
• Principal Display Panel

FULL PRESCRIBING INFORMATION

Active ingredient

Each 5 ml (teaspoonful) contains docusate sodium 50 mg.

Purpose

Stool Softener Laxative

Keep Out of Reach of Children

Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

Docusate Sodium Uses

For relief of occasional constipation due to hard stools. The effect on stools is usually apparent 1 to 3 days after the first dose.

Warnings

Do not use laxative products when abdominal pain, nausea, or vomiting are present, or use for a period longer than 1 week, 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. Rectal bleeding or failure to have a bowel movement after the use of a laxative may indicate a serious condition. Discontinue use and consult you physician. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. May cause rash in some cases.

DRUG INTERACTION PRECAUTION: Do not take this product if you are presently taking mineral oil or a prescription drug, unless directed by a physician.

Directions

As directed by a physician or once daily as follows: Adults and children 12 years of age and over: oral dosage is 5 to 20 mL (1 to 4 teaspoonfuls). Children 6 to under 12 years of age: oral dosage is 5 to 10 mL (1 to 2 teaspoonfuls). Children 3 to under 6 years of age: oral dosage is 2.5 to 5 mL (1/2 to 1 teaspoonful). Children under 3 years of age: consult a physician. The higher doses are recommended for initial therapy. Dosage should be adjusted to individual response. If desired, the product may be administered in a 6 to 8 oz glass of milk or fruit juice or in infant formula to mask the bitter taste.

Inactive ingredients

Sugar Free

Citric acid, D&C Red No. 33, flavoring, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.

Sodium Content: 14 mg/5 ml

Indications

For the relief of occasional constipation due to hard stools. The effect on stools is usually apparent 1 to 3 days after the first dose.

Drug Interaction Precaution

Do not take this product if you are presently taking mineral oil or a prescription drug, unless directed by a physician.

How Supplied

Purple colored, cherry flavored liquid supplied in the following oral dosage forms: NDC 0121-0544-10

(unit dose cups of 10 mL, 10 x 10's), NDC 0121-0544-25

(unit dose cups of 25 mL, 10 x 10's), and NDC 0121-0544-16

(16 fl oz bottle).

Storage

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from freezing. Protect from light.

Pharmaceutical Associates, Inc.

Greenville, SC 29605

R01/01

Principal Display Panel

Docusate Sodium Liquid

100 mg/10 ml

Stool Softener Laxative

5 Unit Dose Cups