FDA Label for Docusate Sodium

View Indications, Usage & Precautions

ACTIVE INGREDIENT (IN EACH SOFTGEL)
PURPOSE
USES
WARNINGS
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
PRINCIPAL DISPLAY PANEL – CARTON – 100 MG
PRINCIPAL DISPLAY PANEL - BLISTER – 100 MG

Docusate Sodium Product Label

The following document was submitted to the FDA by the labeler of this product American Health Packaging. 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 100 mg

Purpose

Stool softener laxative

Uses

for relief of occasional constipation (irregularity)
generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

if you are currently taking mineral oil, unless directed by a doctor
when abdominal pain, nausea or vomiting are present unless directed by a doctor
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 2 weeks.

Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use of a laxative. This may indicate a serious condition.

If pregnant or breast-feeding, ask a health care 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

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

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

Other Information

Each softgel contains: sodium 7 mg VERY LOW SODIUM
Store at room temperature between 15° to 30°C (59° to 86°F)
FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin USP, Glycerin USP, Polyethylene Glycol 400 NF, Purified Water USP, Sorbital USP

The drug product contained in this package is from NDC # 61301-8001, SWISSCAPS Romania srl.

Distributed by:
American Health Packaging
2550 John Glenn Avenue, Suite A
Columbus, OH 43217

712901
0412901/0216PS

Principal Display Panel – Carton – 100 Mg

NDC 60687-129-01

DOCUSATE SODIUM, USP
Stool Softener Laxative

100 mg

100 Softgels (10 x 10)

The drug product contained in this package is from NDC # 61301-8001,
SWISSCAPS Romania srl.