Active Ingredient(S)
Docusate sodium 100mg
Topcare Stool Softener Capsule, Liquid Filled
FDA Label NDC 76162-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Topcare Stool Softener (NDC 76162-006). 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(s), purpose, use(s), do not use, ask a doctor before use if, stop use and ask a doctor if, pregnancy/breastfeeding, 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
Use(S)
- 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 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.
- you need to use a stool softener laxative for more than 1 week
Pregnancy/Breastfeeding
ask a health professional before use.
Keep Out Of Reach Of Children
In case of accidental overdose, get medical help or contact a Poison Control Center
(1-800-222-1222) right away.
Directions
Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
- Adults 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 capsule contains: sodium 5mg
- VERY LOW SODIUM
Storage
- store 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)
Inactive Ingredients
Black edible ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special
Questions
Call 1-888-952-0050 Monday through Friday 9am-5pm
Principal Display Panel
Stool Softener (420 Topcare Stool Softener 1)
Stool Softener (420 Topcare Stool Softener 2)
* Please review the disclaimer below.
