Otc - Active Ingredient
Active Ingredient (In each softgel)
Docusate Sodium.... 100 mg
Docusate Sodium Capsule, Liquid Filled
FDA Label NDC 24689-130
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apnar Pharma Lp for the product Docusate Sodium (NDC 24689-130). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Stool softener laxative
Indications & Usage
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Warnings
Warnings
Do not use
if you are presently taking mineral oil, unless told to do so by a doctor.
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that last over 2 weeks
- you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be a signs of a serious condition.
- you need to use a stool softner laxative for more than 1 week
Stop use and ask a doctor if
If pregnant or breast-feeding,
ask a health professional before use.
Otc - 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 (1-800-222-1222) right away.
Dosage & Administration
Directions
take only by mouth. 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
Storage And Handling
Other Information
each softgel contains: sodium 5 mg
store between 20°C - 25°C (68-77°F);excursions permitted between 15-30°C (59-86°F)
Inactive Ingredient
Gelatin, Glycerin, Sorbitol Sorbitan solution, Purified water , D&C Red #40, D&C Yellow #6, White Ink
Otc - Questions
Questions or Comments ?
Call 1-855-642-2594
Other
Compare to the active ingredient in Colace® Regular Strength Stool Softener†
†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener.
Rev.: 03/2023
Manufactured by:
Apnar Pharma LLP
East Windsor, NJ 08520
Package Label.Principal Display Panel
NDC 24689-130-01
Docusate Sodium 100mg
Stool Softener Laxative
MADE IN USA
100 Softgels
* Please review the disclaimer below.
