FDA Label for Docusate Sodium 100mg
View Indications, Usage & Precautions
Docusate Sodium 100mg Product Label
The following document was submitted to the FDA by the labeler of this product Pharmaceutica North America, 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
Docusate sodium 100 mg
Purpose
Stool softener laxative
Uses
• relieves occasional constipation (irregularity)
• generally produces bowel movement in 12 to 72 hours
Warnings
Do not use
if you are presently taking mineral oil, unless told to do so by a doctor.
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
If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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 1-3 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 7 mg
• store at 25°C (77°F); excursion permitted between 15-30°C (59-86°F)
Inactive Ingredients
citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink
Product Label
* Please review the disclaimer below.
