FDA Label for Stool Softener
View Indications, Usage & Precautions
Stool Softener Product Label
The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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(S)
Docusate sodium 100mg
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
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