Active Ingredients (In Each Tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Stool Softener Tablet
FDA Label NDC 67091-328
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Stool Softener (NDC 67091-328). 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 to12 hours
Do Not Use
- laxative products for longer than 1 week unless directed by a doctor
- if you are now 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 30 mg
- each tablet contains: sodium 6 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 blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol*, silcon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide
*contains one or more of these ingredients
Questions Or Comments?
Call 1-800-824-1706 Monday-Friday 9AM-4PM MST
Principal Display Panel
Compare to the active ingredients in Colace®2-IN-1
Stool Softener
& Stimulant Laxative
DOCUSATE SODIUM 50 mg/
STOOL SOFTENER
SENNOSIDES 8.6 mg/
STIMULANT LAXATIVE
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: WINCO FOODS, LLC, BOISE, ID 83704
Product Label
WINCO FOODS Stool Softener & Stimulant Laxative
* Please review the disclaimer below.
