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 Pd-rx Pharmaceuticals, 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)
- results usually occurs 1 to 3 days after the first dose
Do Not Use
Do not use if you are currently taking mineral oil, unless directed bya doctor
Ask A Doctor Before Use If You
- stomach pain, nausea or vomiting
- have noticed a sudden change in bowel habits that last 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 softner 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
- do not exceed recommended dose
| adults and children over 12 years and older
| take 1-3 softgels daily
|
| children 2 to 12 years of age
| take 1 softgel daily
|
| children under 2 years
| ask a doctor
|
Other Information
- Each capsule contains sodium 6mg
- 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
How Supplied
Cyclobenzaprine hydrochloride tablets, USP are available in 5 mg dosage strength.
The 5 mg tablets are supplied as orange film coated round shaped biconvex tablets debossed “K 6” on one side and plain on other side.
Bottles of 14, 30, 60, 90 and 180 softgels.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [see USP Controlled Room Temperature].
Dispense in a tight, well-closed, container as defined in the USP, with a child-resistant closure (as required).
Principal Display Panel
*Compare to the active ingredient of Colace®
Docusate Sodium
Stool Softener
100 mg each
* Please review the disclaimer below.