Active Ingredient (In Each Softgel)
Docusate calcium 240 mg
Stool Softener
FDA Label NDC 76413-324
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Central Texas Community Health Centers for the product Stool Softener (NDC 76413-324). 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 (in each softgel), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool softener laxative
Uses
- for relief of occasional constipation
- this product generally produces a bowel movement within 12 to 72 hours
Do Not Use
if you are currently taking mineral oil, unless directed 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 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 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.
Directions
- adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
- children under 12 years of age: ask a doctor
Other Information
- store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
corn oil, D&C red #33*, edible white ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6*, gelatin, glycerin, purified water, sorbitol special
*contains one or more of these ingredients
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel - 240 Mg Capsule Bottle Label
CommUnityCare Federally Qualified Health Centers
DOCUSATE
CALCIUM
240 MG
CAPS
Date:
Name:
Dr.
TAKE 1 CAPSULE BY MOUTH DAILY AS DIRECTED.
123456
1/1/01
DOCUSATE CA.240MG CAPS#30NDC 76413-324-30
Batch: 123456
Lot: 123456
Exp: 1/1/01
SUNMARK
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
Principal Display Panel (240 MG Capsule Bottle Label)
* Please review the disclaimer below.
