FDA Label for Docusate Sodium
View Indications, Usage & Precautions
Docusate Sodium Product Label
The following document was submitted to the FDA by the labeler of this product Direct_rx. 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.
Otc - Active Ingredient
Docusate Sodium 100 mg
Purpose
Stool softener
Indications & Usage
for prevention of dry, hard stools
for relief of occasional constipation
This product 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
for longer than 1 week, unless directed by a doctor
Ask a doctor before use if
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
you fail to have a bowel movement after use
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health care professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
adults and children over 12 years of age take 1 to 3 softgels preferably at bedtime
children 6-12 years of age take 1 softgel at bedtime
children under 6 years ask a doctor
Other Safety Information
each softgel contains: sodium 6 mg
store between 15°-30°C (59°-86°F)
Inactive Ingredient
edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.
Otc - Questions
1-800-645-2158
Package Label.Principal Display Panel
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