Active Ingredient (In Each Softgel)
Docusate Sodium 100 mg
Stool Softener Laxative Capsule, Liquid Filled
FDA Label NDC 82804-097
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Stool Softener Laxative (NDC 82804-097). 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, 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
- 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
- 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 using a laxative. These could be a sign 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 care professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-2222-1222) right away.
Directions
- take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over | take 1-3 softgels daily |
children 2 to under 12 years of age | take 1 softgel daily |
children under 2 years | ask a doctor |
Other Information
- each softgel contains: sodium 7 mg
- store at 25°C (77°F); excursion permitted between 15-30°C (59-86°F)
Inactive Ingredients
citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitol special, white edible ink
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in Colace® Regular Strength Stool Softener†
DOCUSATE SODIUM, 100 mg
STOOL SOFTENER LAXATIVE
Gentle, Dependable
Stimulant-free
SOFTGELS
†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener..
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
RELABELED BY:
Proficient Rx LP
Thousand Oaks, CA 91320
Product Label
Stool Softener Laxative
* Please review the disclaimer below.
