Active Ingredients (In Each Tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Stool Softener Laxative Tablet
FDA Label NDC 36800-555
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Top Care (topco Associates Llc) for the product Stool Softener Laxative (NDC 36800-555). 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
- relieves 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 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 could be signs of 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
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, silicon dioxide, talc*, titanium dioxide
Questions Or Comments?
Call toll free 1-888-423-0139
Principal Display Panel
COMPARE TO COLACE® 2-IN-1 ACTIVE INGREDIENT†
Stool Softener
Plus Stimulant Laxative
DOCUSATE SODIUM 50 mg STOOL SOFTENER
SENNOSIDES 8.6 mg STIMULANT LAXATIVE
For Overnight Relief Of Occasional Constipation
- Effective
- Reliable
- Comfortable
TABLETS
GLUTEN FREE
†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.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY: TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
Product Label
TOPCARE HEALTH Stool Softener Laxative
* Please review the disclaimer below.
