Active Ingredient (In Each Softgel)
Sennosides 8.6 mg
Senna
FDA Label NDC 36800-135
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Top Care (topco Associates Llc) for the product Senna (NDC 36800-135). 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, do not use, ask a doctor before using 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 produces a bowel movement in 6-12 hours
Do Not Use
- laxative products for longer than 1 week unless directed by a doctor
Ask A Doctor Before Using If You Have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that continues 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 overdose, get medical help or contact a Poison Control Center 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 and over | 2 tablets once a day | 4 tablets twice a day |
| children 6 to under 12 years | 1 tablet once a day | 2 tablets twice a day |
| children 2 to under 6 years | 1/2 tablet once a day | 1 tablet twice a day |
| children under 2 years | ask a doctor | ask a doctor |
Other Information
- each tablet contains: calcium 1mg and sodium less than 1mg
- store at 25 oC (77 o F); excursions permitted between 15 _30 oC (59 _86 oF)
Inactive Ingredients
aerosil, beeswax, FD&C Blue No. 1, FD&C Red No.40, FD&C Yellow No. 6, gelatin, glycerin,
light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethyl cellulose,
sorbitol solution, soya lecithin, titanium dioxide
Questions Or Comments?
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COMPARE TO SENOKOT® ACTIVE INGREDIENT*
Laxative
SENNOSIDES 8.6 mg • LAXATIVE
Gentle, Overnight Relief
60 SOFTGELS
actual size
Image Description (Senna)
* Please review the disclaimer below.
