Active Ingredient (In Each Softgel)
Docusate sodium 100 mg
Stool Softener Laxative Capsule, Liquid Filled
FDA Label NDC 63981-853
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Costco Wholesale for the product Stool Softener Laxative (NDC 63981-853). 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
- 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 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 (1-800-222-1222) right away.
Directions
- take only be mouth. Doses may be taken as a single daily dose or in divided doses.
| adult 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 6 mg
- store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
Inactive Ingredients
black iron oxide, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COMPARE TO COLACE® STOOL SOFTENER active ingredient†
STOOL SOFTENER
Stool Softener Laxative
Docusate Sodium, 100 mg
Gentle, Effective Relief
- Stimulant-free for Comfortable Relief
- Relieves Constipation
SOFTGELS
GLUTEN FREE
†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: PL Developments
Westbury, NY 11590 U.S.A.
For: Costco Wholesale Corporation
P.O. Box 34535, Seattle, WA 98124-1535 USA
Product Label
KIRKLAND SIGNATURE (Costco) Stool Softener Laxative
* Please review the disclaimer below.
