FDA Label for Stool Softener
View Indications, Usage & Precautions
Stool Softener Product Label
The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Docusate Sodium 100 mg
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
Sunmark
COMPARE TO COLACE®
ACTIVE INGREDIENT*
NDC 49348-167-10
Stool Softener
For relief of occasional constipation
Docusate Sodium 100 mg
100 Tablets
* Please review the disclaimer below.