Active Ingredient (In Each Softgel)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Docusate Sodium And Sennosides Capsule, Liquid Filled
FDA Label NDC 35916-0477
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 Private Limited for the product Docusate Sodium And Sennosides (NDC 35916-0477). 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, otc - ask doctor, otc - stop use, otc - pregnancy 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
Laxative
Uses
- relieves occasional constipation (irregularity)
- generally causes bowel movement in 6-12 hours
Warnings
Do not use
- if you are now taking mineral oil, unless directed by a doctor
- laxative products for longer than 1 week, unless directed by a doctor
Otc - Ask Doctor
Ask a doctor if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel movements that continues over a period of 2 weeks
Otc - Stop Use
Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
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.
Dosage & Administration
Directions
take preferably at bedtime or as directed by a doctor.
| Age | Starting Dosage | Maximum Dosage |
| adults and children 12 years of age and older | 2 softgels once a day | 4 softgels twice a day |
| children 6 to 12 years | 1 softgel once a day | 2 softgels twice a day |
| children under 6 years of age | ask a doctor | ask a doctor |
Other Safety Information
Other information
each softgel contains: Sodium 3 mg
store at 25°C (77°F); excursions permitted between 15°- 30°C (59°- 86°F)
Inactive Ingredients
colloidal silicon dioxide, FD&C yellow no.6, gelatin, glycerin, polyethylene glycol 400, povidone K 30, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide, yellow wax.
Package Label.Principal Display Panel
Label (Docusate Senna)
* Please review the disclaimer below.
