Active Ingredient (In Each Softgel)
Docusate sodium 100 mg
Docusate Sodium 100mg Capsule, Liquid Filled
FDA Label NDC 85786-502
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Docusate Sodium 100mg (NDC 85786-502). 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, warnings, do not use if, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stool softener laxative
Uses
. Relieves occasional constipation (irregularity)
. Generally produces bowel movement in 12 to 72 hours
Warnings
Warnings
Do Not Use If
if you are presently taking mineral oil, unless directed to so by a doctor.
Ask A Doctor Before Use If You Have
. stomach pain - nausea . vomiting . noticed a sudden change in bowel habits that lasts over 2 weeks
Stop Use And Ask A Doctor If
. You have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
. 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.
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 12 years and older - Take 1-3 softgels once daily or in divided doses
Children under 12 years old - Take 1 softgel once daily
Children under 2 years - Ask a doctor
Other Information
. Each softgel contains: sodium 5mg
. Store at room temperature 15-30°C (59-86°F)and avoid excessive heat
Inactive Ingredients
Citric acid, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink.
Questions Or Comments?
(855)-280-1079
Other
*This product is not affiliated with the owner of the trademark Colace®
Distributed in USA by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX,
78701, USA
[email protected]
www.drsimi.com
Package Label.Principal Display Panel
Dr. Simi
Compare to the active ingredient in Colace®*
NDC: 85786-502-24
Docusate Sodium 100 mg
Stool Softener
Laxative
24 softgels
* Please review the disclaimer below.
