Stool Softener Regular Strength
FDA Label NDC 68210-4176
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Stool Softener Regular Strength (NDC 68210-4176). 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 drug facts, active ingredient (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Docusate sodium 100 mg
Purpose
Stool softener
Uses
• relieves occasional constipation (irregularity) • generally produces bowel movement in 12–72 hours
Warnings
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
• fever • mucus in the stool
Ask A Doctor Or Pharmacist Before Use If You Are If You Have
• stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 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
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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 asingle daily dose or in divided doses.
| adults & children 12 years of age & over | take 1–3 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
• store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F) • Keep tightly closed
Inactive Ingredients
FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution
Questions Or Comments?
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