Active Ingredients (In Each Tablet)
Docusate sodium 50 mg
Sennosides 8.6 mg
Senna S Capsule, Liquid Filled
FDA Label NDC 83059-0120
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Senna S (NDC 83059-0120). 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 ingredients (in each tablet), purpose, uses, do not use, 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
Laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6-12 hours
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
Ask A Doctor Before Use If You Have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that continues over a periodof 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 may indicate a serious condition.
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 (1-800-222-1222) right away.
Directions
- take preferably at bedtime or as directed by a doctor
| age | starting dosage | maximum dosage |
| adults and children 12 years of age or older | 2 softgels once a day | 4 softgels twice a day |
| children 6 to under 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 Information
- each softgel contains: calcium 3 mg
- store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
Inactive Ingredients
Colloidal Silicon Dioxide, FD&C Red 40, FD&C yellow No. 6, Gelatin, Glycerin, Polyethylene Glycol -400, Propylene Glycol, Povidone (PVPK-30), Purified Water, Sorbitol Sorbitan Solution, Titanium Dioxide, yellow bees wax
Questions Or Comments?
Call 1-800-373-6981 Monday-Friday 9AM-5PM EST
Other
Distributed by:
Shield Pharmaceuticals LLCRonkonkoma, NY 11779
Package Label.Principal Display Panel
Senna-S
Docusate Sodium 50 mg and
Sennosides 8.6 mg
Label
Label-front (Label Front)
Label-back (Label Back)
* Please review the disclaimer below.
