FDA Label for Docusate Sodium

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH SOFTGEL)
PURPOSE
KEEP OUT OF REACH OF CHILDREN.
USES
DO NOT USE:
ASK A DOCTOR BEFORE USE
STOP USE AND ASK A DOCTOR
IF YOU ARE PREGNANT OR BREAST-FEEDING,
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS
PRINCIPAL DISPLAY PANEL

Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 107, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Softgel)

Docusate Sodium 250 mg

Purpose

Stool Softener

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Uses

•For the relief of occasional constipation.
•Helps to prevent dry, hard stools.
•This product generally produces a bowel movement within 12 to 72 hours.

Do Not Use:

•If you are currently taking mineral oil, unless directed by a doctor.
•When abdominal pain, nausea, or vomiting are present.
•For longer than one week unless directed by a doctor.

Ask A Doctor Before Use

if you notice a sudden change in bowel habits that persists over a period of two weeks.

Stop Use And Ask A Doctor

if you have rectal bleeding or you fail to have a bowel movement after use.

If You Are Pregnant Or Breast-Feeding,

ask a healthcare professional before use.

Directions

Adults and Children over 12 years of age	Take orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor.
Children under 12 years of age	Do not use this product for children under 12 years of age, unless directed by a doctor.

Other Information

•Each softgel contains 13 mg of Sodium.
•Store at room temperature between 15°C to 30°C (59°F to 86°F).
•For identification purposes, each softgel will have an imprint that reads NV12.

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol

Questions

Call 1-855-361-3993

Principal Display Panel

Docusate Sodium, USP