FDA Label for Docusate Sodium

View Indications, Usage & Precautions

OTHER
ACTIVE INGREDIENT (IN EACH SOFTGEL)
PURPOSE
USES
DO NOT USE
OTC - ASK DOCTOR
STOP USE AND ASK A DOCTOR IF
OTC - PREGNANCY OR BREAST FEEDING
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
HOW SUPPLIED
OTC - QUESTIONS
PRINCIPAL DISPLAY PANEL - 250 MG SOFTGEL BLISTER PACK CARTON

Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Precision Dose, Inc.. 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.

Other

Drug Facts

Distributed by:
National Vitamin Company
Casa Grande, AZ 85122

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

LI1459 Rev. 06/21

Active Ingredient (In Each Softgel)

Docusate Sodium 250 mg

Purpose

Stool Softener

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.

Otc - Ask Doctor

Ask a doctor before use if you noticed 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.
You fail to have a bowel movement after use.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Directions

Adult 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 25°C (59°F to 77°F).

Inactive Ingredients

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

How Supplied

NDC 68094-052-61
Unit Dose Packages of 100 Softgels (10×10) per Carton

Otc - Questions

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]

Principal Display Panel - 250 Mg Softgel Blister Pack Carton

Precision Dose™

NDC 68094-052-61
Unit Dose

Docusate Sodium, USP
250 mg Softgels

100 Softgels
(10 x 10)

(in each softgel)
Docusate Sodium 250 mg Stool Softener

Each softgel contains 13 mg of Sodium.

USUAL DOSE: SEE ENCLOSED INSERT.

Store at room temperature between
15°C to 25°C (59°F to 77°F).

Keep out of reach of children.

Hospital Use Only.

LC1458
R0