Active Ingredient (In Each Softgel)
Docusate Sodium USP 100 mg
Docusate Sodium
FDA Label NDC 35916-0440
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Softgel Healthcare Pvt Ltd for the product Docusate Sodium (NDC 35916-0440). 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, ask a doctor before use if you have, 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)
- generally produces bowel movement in 12 to 72 hours
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
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
In case of overdose, get medical help or contact a Poison Control Center right away.
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 1-3 capsules daily |
| children 2 to under 12 years of age | take 1 capsule daily |
| children under 2 years | ask a doctor |
Other Information
- each softgel contains: Sodium 5 mg
- store at 25°C (77°F); excursion permitted between 15°-30°C (59°-86°F).
Keep tightly closed.
Inactive Ingredient
FD&C red no.40, FD&C yellow no.6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol sorbitan solution, water.
Tamper Evident
Do not use if safety seal under cap is broken or missing
Manufactured By
Softgel Healthcare Pvt. Ltd.,
Survey No. 20/1,
Vandalur-Kelambakkam Road,
Pudupakkam Village,
Kancheepuram District,
Tamilnadu - 603 103, India.
Mfg. Lic. No.: XXXXXXXXXXXX
* Please review the disclaimer below.
