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 Mckesson Corporation. 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 Capsule)
Docusate Sodium 100mg
Purpose
Stool Softener
Uses
- for the prevention of dry, hard stools
- for relief of occasional constipation.
- This product generally produces a bowel movement within 12 to 72 hours.
Warnings
Do not use
- if you are currently taking mineral oil, unless directed by a doctor
- when abdominal pain, nausea, or vomiting are present
- for longer than 1 week unless directed by a doctor
- you have rectal bleeding
- you fail to have a bowel movement after use
Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.
Stop use and ask a doctor if
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 over 12 years of age: take 1-2 capsules, preferably at bedtime
- Children 6-12 years of age: take 1 capsule at bedtime
Other Information
- each capsule contains: sodium 5 mg
- store at controlled room temperature 15° - 30°C (59° - 86°F)
Inactive Ingredients
FD&C red #40, gelatin, glycerin, polyethylene glycol, propyleneglycol and sorbitol special. May also contain: D&C yellow #10, FC&C yellow #6 and purified water.
How Supplied
Product: 63739-478
* Please review the disclaimer below.