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 Contract Pharmacy Services-pa. 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
- prevents/relieves dry hard stool
- results usually occurs 1 to 3 days after the first dose
Do Not Use
- when abdominal pain, nausea, or vomiting are present
- for more than one week unless directed by a doctor
Ask A Doctor Before Use If You
- are taking mineral oil
- have noticed a sudden change in bowel habits that last over 2 weeks
Stop Use And Ask A Doctor If
- you have no bowel movement after 3 days
- you have rectal bleeding
These could be signs of a serious condition
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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 over 12 years
| take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
|
| children 6 to 12 years
| take 1 softgel daily
|
| children under 6 years
| consult a doctor
|
Other Information
- Tamper Evident: Do not use if safety seal under cap is broken or missing
- store at room temperature 15 o to 30 oC (59 o to 86 oF)
- protect from moisture
Questions?
Adverse drug event call: (866) 562-2756
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