Active Ingredient (In Each Softgel)
Docusate Sodium 100 mg
Stool Softener Laxative Capsule
FDA Label NDC 72476-862
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Care One (retail Business Services, Llc.) for the product Stool Softener Laxative (NDC 72476-862). 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
Stool Softener Laxative
Uses
- for relief of occasional constipation and irregularity
- this product generally produces a bowel movement in 12 to 72 hours.
Do Not Use
if you are presently taking mineral oil, unless directed by a doctor
Ask A Doctor Before Use If You Have
- stomach pain
- nausea
- vomiting
- a sudden change in bowel habits that lasts more than 2 weeks
Stop Use And Ask A Doctor If
- you have rectal bleeding or no bowel movement after using 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 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.
Directions
- take with a glass of water
| adults and children 12 years and over | take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. |
| children 2 to under 12 years of age | take 1 softgel daily |
| children under 2 years of age | ask a doctor |
Other Information
- each softgel contains: sodium 5 mg
- store at 25oC (77o); excursions permitted between 15-30oC (59-86oF)
Inactive Ingredients
edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol
Questions Or Comments ?
Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST
Principal Display Panel
Compare to the active ingredient in Dulcolax® Stool Softener†
STOOL SOFTENER LAXATIVE
Docusate Sodium 100 mg
FAST, DEPENDABLE RELIEF OF OCCASIONAL CONSTIPATION
SOFTGELS
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DISTRIBUTED BY FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
Product Label
CAREONE Stool Softener Laxative
* Please review the disclaimer below.
