FDA Label for Stool Softener Laxative

Active Ingredient (In Each Softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

• relieves occasional constipation (irregularity)
• generally produces bowel movement in 12 to 72 hours

Do Not Use

if you are presently taking mineral oil, unless told to do so by a doctor.

Ask A Doctor Before Use If You Have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that last over 2 weeks

Stop Use And Ask A Doctor If

• you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be a signs of a serious condition.
• you need to use a laxative for more than 1 week

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222)  right away.

Directions

• take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over	take 1 to 3 softgels daily.
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years	ask a doctor

Other Information

• each softgel contains: sodium 5 mg
• store at 25°C (77°F);excursions permitted between 15-30°C (59-86°F)

Inactive Ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol

Questions Or Comments?

 Call 1-800-616-2471

Principal Display Panel

DRUG: Stool Softener Laxative

GENERIC: DOCUSATE SODIUM

DOSAGE: CAPSULE

ADMINSTRATION: ORAL

NDC: 70518-3049-0

COLOR: orange

SHAPE: OVAL

SCORE: No score

SIZE: 12 mm

IMPRINT: P51

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

• DOCUSATE SODIUM 100mg in 1

INACTIVE INGREDIENT(S):

• FD&C RED NO. 40
• FD&C YELLOW NO. 6
• GELATIN
• SORBITAN
• POLYETHYLENE GLYCOL, UNSPECIFIED
• PROPYLENE GLYCOL
• WATER
• SORBITOL
• GLYCERIN
• MEDIUM-CHAIN TRIGLYCERIDES

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