Active Ingredient (In Each Tablet)
Sennosides 8.6 mg
Senna Laxative Tablet
FDA Label NDC 70677-1097
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Senna Laxative (NDC 70677-1097). 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 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 produces 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 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 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 30 mg
- store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
Inactive Ingredients
croscarmellose sodium, anhydrous dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, talc, triacetin
Questions Or Comments?
Call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST
Principal Display Panel
COMPARE TO SENOKOT® ACTIVE INGREDIENT*
REGULAR STRENGTH
Senna laxative
Sennosides 8.6 mg
LAXATIVE
Natural Vegetable Laxative Ingredient
- Gentle Dependable
- Overnight Relief
TABLETS
*This product is not manufactured or distributed by Avrio 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 McKesson Corp.,
via Strategic Sourcing Services LLC,
Memphis, TN 38141
www.fosterand thrive.com
Product Labeling
FOSTER & THRIVE Senna Laxative
* Please review the disclaimer below.
