Active Ingredient (In Each Softgel)
Docusate sodium 100 mg
Docusate Sodium Capsule
FDA Label NDC 55289-493
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pd-rx Pharmaceuticals, Inc. for the product Docusate Sodium (NDC 55289-493). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each softgel), purpose, uses, do not use, ask a doctor before use if you, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
55289493 Label (55289493)
* Please review the disclaimer below.
