Active Ingredient
Docusate Sodium 100 mg
Stool Softener Tablet
FDA Label NDC 57896-421
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceuticals, Corp for the product Stool Softener (NDC 57896-421). 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 Laxative
Uses
- relieves occasional constipation (irregularity)
- 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.
Directions
- adults and children 12 years and older: take 1-2 tablets daily until first bowel movement; 1 tablet daily thereafter, or as directed by doctor
- children under 12: consult a doctor
- do not exceed recommended dose
Other Information
- each tablet contains: calcium 50 mg, sodium 8 mg
- for institutional use only
- package not child resistant
- store at room temperature 15°C-30°C (59°F-86°F)
- Tamper Evident: Do not use if imprinted seal under cap is missing or broken
Inactive Ingredients
cellulose, croscarmellose sodium, dicalcium phosphate, magnesium stearate, silica, stearic acid, talc
Package Label
Gericare
NDC 57896-421-10
Stool
Softener
TABLETS
Docusate Sodium
1000 Tablets
100 mg each
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