Active Ingredient(S)
Docusate sodium 100mg
Stool Softener Capsule
FDA Label NDC 69168-420
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Stool Softener (NDC 69168-420). 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 active ingredient(s), purpose, use(s), do not use, ask a doctor before use if, stop use and ask a doctor if, pregnancy/breastfeeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool softener
Use(S)
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 lasts over a period of 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 signs of a serious condition.
you need to use a stool softener laxative
for more than 1 week
Pregnancy/Breastfeeding
ask a
health professional before use.
Directions
Take only by mouth. Doses may be
taken as a single daily dose or in divided
doses.
Adults and children take 1-3 softgels,
12 years and over: daily
Children 2 to under take 1 softgel
12 years of age: daily
Children under ask a doctor
2 years
Other Information
each capsule contains: sodium 5mg
VERY LOW SODIUM
Storage
store at 25°C (77°F) excursions
permitted between 15°– 30°C
(59°–86°F)
Inactive Ingredients
black edible ink, citric acid, D&C red #33,
FD&C blue #1, FD&C red #40, FD&C
yellow #6, gelatin, glycerin, polyethylene
glycol, propylene glycol, purified water,
sorbitol special
Questions
Call 1-888-952-0050 Monday through
Friday 9am-5pm
Principal Display Panel
Docusate Sodium (420 Stool Softener 1)
* Please review the disclaimer below.
