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 Puracap Pharmaceutical 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 (In Each Softgel)
Docusate sodium 100 mg
Purpose
Stool softener
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
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.
- you need to use a stool softener laxative for more than 1 week
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 to 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 softgel contains: sodium 5 mg
- VERY LOW SODIUM
- store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
Inactive Ingredients
Black 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, sorbitol special and purified water
Questions Or Comments?
Call toll free: 1-800-833-6278
Principal Display Panel
STOOL SOFTENER
DOCUSATE SODIUM 100mg 100SOFTGELS
Compare to the active ingredient in COLACE®
NDC 51013-122-14
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