Active Ingredient (In Each Tablet)
Sennosides 8.6 mg
Senna Tablet
FDA Label NDC 83324-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Senna (NDC 83324-004). 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 tablet), 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 (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 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 tablets once a day | 1 tablet twice a day |
| children under 2 years | ask a doctor | ask a doctor |
Other Information
- each tablet contains: calcium 30 mg
- store at 25o C (77o F); excursions permitted between 15-30°C (59-86°F)
Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, talc, triacetin
Questions Or Comments?
Call 1-800-935-2362 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to the Active Ingredient in Senokot®
Laxative Regular Strength
Laxative
Sennosides 8.6 mg
Natural Vegetable Laxative Ingredient
Provides Gentle Relief of:
Occasional Constipation
Tablets
*This product is not manufactured or distributed by Aviro Health L.P., distributor of Senokot®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by CDMA, Inc.
Novi, MI 48375
Product Label
QUALITY CHOICE Regular Strength Laxative
* Please review the disclaimer below.
