Active Ingredients (In Each Tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Stool Softener Tablet
FDA Label NDC 21130-878
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway, Inc. for the product Stool Softener (NDC 21130-878). 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 ingredients (in each tablet), 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
Stimulant laxative
Uses
- for overnight relief from occasional constipation (irregularity)
- generally produces bowel movement in 6 to 12 hours
Do Not Use
- laxative products for longer than 1 week unless told to do so by a doctor
- if you are presently 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 a period of 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 may indicate a serious condition.
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
- Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses
| adults and children 12 years and older | take 2-4 tablets daily |
| children 6 to under 12 years of age | take 1-2 tablets daily |
| children 2 to under 6 years of age | take up to 1 tablet daily |
| children under 2 | ask a doctor |
Other Information
- each tablet contains: calcium 21 mg
- each tablet contains: sodium 5 mg VERY LOW SODIUM
- store at 25°C(77°F);excursions permitted between 15-30°C(59-86°F)
Inactive Ingredients
carnauba wax, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium benzoate, stearic acid, titanium dioxide
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COMPARE TO Colace® 2-IN-1 active ingredients*
Stool Softener
Plus Stimulant Laxative
DOCUSATE SODIUM 50 mg
SENNOSIDES 8.6 mg
For overnight relief of occasional constipation
- Gentle
- Dependable
Relief in 6-12 hours
TABLETS
*This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY
BETTER LIVING BRANDS LLC
P.O. BOX 99 PLEASANTON, CA 94566-0009
Product Label
SIGNATURE CARE Stool Softener Laxative
* Please review the disclaimer below.
