Active Ingredient
Docusate Sodium 100 mg
Stool Softener Tablet
FDA Label NDC 70677-1071
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Stool Softener (NDC 70677-1071). 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, purpose, uses, warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool Softener
Uses
- relieves occasional constipation (irregularity)
- this product generally produces bowel movement in 12 to 72 hours
Warnings
Ask a doctor before use if you
- have stomach pain, nausea or vomiting
- have a sudden change in bowel habits that persists over a period of 2 weeks
- are presently taking mineral oil
- you need to use a laxative longer than 1 week
- you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition.
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (800) 222-1222.
Directions
- adults and children 12 years and older: take 1-3 tablets daily, or as directed by a doctor. May be taken as a single daily dose or in divided doses.
- children under 12: ask a doctor
- do not exceed recommended dose
Other Information
- each tablet contains: calcium 50 mg, sodium 10 mg
- store at room temperature 15°C-30°C (59°F-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
cellulose, croscarmellose sodium, dicalcium phosphate, magnesium stearate, silica, sodium benzoate, stearic acid, talc
Questions Or Comments?
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Package Label
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