Active Ingredients (In Each Tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Stool Softener Tablet
FDA Label NDC 21130-902
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands Llc. for the product Stool Softener (NDC 21130-902). 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, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, 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 to 12 hours
Warnings
Warnings
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 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.
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 (1-800-222-1222).
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 20 mg, 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, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide
Questions Or Comments?
Call 1-877-290-4008
Package Label.Principal Display Panel
Alb-doc-sen-200-label (Alb Doc Sen 200 Label)
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