Active Ingredient (In Each Softgel)
Sennosides USP 8.6 mg
Sennosides Capsule, Liquid Filled
FDA Label NDC 35916-1936
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 Sennosides (NDC 35916-1936). 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, 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
Laxative
Uses
- relieves occasional constipation (irregularity)
- generally causes a bowel movement in 6-12 hours
Warnings Do Not Use
- laxative products for longer than 1 week unless directed by a doctor
Ask A Doctor Before Use If You Have
- stomach pain
- nausea
- vomiting
- notice a sudden change in bowel habits that continue over a period of 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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Directions
- do not take more than directed
- take with full glass of water
- take preferably at bedtime or as directed by a doctor
Age Starting Dosage Maximum Dosage adults and children 12 years of age and over 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
- store at room temperature between 20°C - 25°C (68°F - 77°F)
Inactive Ingredients
ferrosoferric oxide, fumaric acid, gelatin, glycerin, lecithin soybean, methyl paraben, purified water, ferric oxide red, sorbitol 70% solution, soy bean oil, yellow bees wax.
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