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 Blenheim Pharmacal, 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
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Do Not Use -
if you are currently taking mineral oil, unless directed by a doctor
Ask A Doctor Before Use If You Have
- stomach pain, nausea or vomiting
- have noticed a sudden change in bowel habits that lasts over 2 weeks
Stop Use And Ask A Doctor If
- you have rectal bleeding
- you fail to have a bowel movement after use
- you need to use a stool softener laxative for more than 1 week
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
- doses may be taken as a single daily dose or in divided doses
| adults and children 12 years and over
| take 1 to 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 capsule contains sodium 6 mg
- store at room temperature 15 o-30 oC (59 o-86 oF)
- Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing
Questions?
Adverse drug event call (800) 687-0176
Principal Display Panel
Blenheim Pharmacal, Inc.
NDC 10544-130-20
Docusate Sodium [Stool Softener] Softgel Capsules, 100mg
20 Softgel Capsules
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