FDA Label for Docusate Sodium
View Indications, Usage & Precautions
Docusate Sodium Product Label
The following document was submitted to the FDA by the labeler of this product Asclemed Usa, Inc.. 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 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
Stop use and ask a doctor if
• 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.
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
• do not exceed recommended dose
• adults and children 12 years and older: take 1-3
softgels daily until first bowel movement; 1 softgel
daily thereafter, or as directed by a doctor
• children under 12: consult a doctor
Other Information
•
each softgel contains: sodium 7 mg. Very low sodium
• store at 59°-77°F (15°-25°C)
• keep tightly closed
•
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, glycerin, PEG, sorbitol special, water.
Package Label
* Please review the disclaimer below.