Clear Stool Softener
FDA Label NDC 55319-618

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Family Dollar (family Wellness) for the product Clear Stool Softener (NDC 55319-618). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient(in each softgel), purpose, uses, warnings, otc - ask doctor/pharmacist, otc - do not use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
MIDWOOD BRANDS, LLC
500 Volvo Pkwy
Chesapeake, VA 23320 USA

Active Ingredient(In Each Softgel)

Docusate sodium 50 mg

Purpose

Stool softener

Uses

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

Warnings

Do not use
■ if you are presently taking mineral oil, unless told to do
so by a doctor

Otc - Ask Doctor/Pharmacist

Ask a doctor before use if you have
■ stomach pain ■ nausea ■ vomiting
■ noticed a sudden change in bowel habits that lasts over
2 weeks

Otc - Do Not Use

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 signs
of a serious condition.
■ you need to use a stool softener laxative for more than
1 week

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. 1-800-222-1222

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 6 softgels
daily
children 2 to under 12 years
of age 		take 1 to 3 softgels
daily
children under 2 yearsask a doctor

Other Information

■ each softgel contains: sodium 0.02 mg 

■ store at 25°C (77°F); excursions permitted between
15°-30°C (59°-86°F). 

Inactive Ingredients

gelatin, glycerin, polyethylene glycol-400, povidone
(PVP K-30), propylene glycol, purified water, sorbitol
solution

Otc - Questions

Questions or comments? 1-888-333-9792

Package Label.Principal Display Panel

Compare to the

active ingredient
in Colace® Clear*

Clear Stool Softener
DOCUSATE SODIUM, 50 mg

* Please review the disclaimer below.