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 Geri-care Pharmaceutical Corp. 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 250 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.
Stop use and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before
use.
Otc - Keep Out Of Reach Of Children
Keep out of 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 softgel daily or as directed by a doctor
- children under 12: do not use
- do not exceed recommended dose
Other Information
- each softgel contains: sodium 15 mg
- store at 59°-77°F (15°-25°C)
- keep tightly closed
- product of Romania
- Package not child resistant
- Tamper Evident: Do not use if imprinted seal under cap is missing or broken
Inactive Ingredients
FD&C red #40, FD&C yellow #6 (sunset yellow),
gelatin, glycerol, PEG, purified water
Questions Or Comments?
1-800-540-3765
Package Label
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