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Drug Facts
Senna Tablet
FDA Label NDC 69618-064
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Reliable 1 Laboratories Llc for the product Senna (NDC 69618-064). 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 other, active ingredient (in each tablet), purpose, uses, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Tablet)
Sennosides 8.6 mg
Purpose
Stimulant laxative
Uses
- relieve occasional constipation (irregularity)
- this product generally produces a bowel movement in 6 to 12 hours
Warnings
Do not use
- Lasative products for longer than 1 week unless directed by a doctor
Otc - Ask Doctor
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that continues over a period of 2 weeks
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Posion Control Center right away.
Other Information
- each tablet contains: calcium 4 mg, sodium 3 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
colloidal sillicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid
Questions Or Comments?
Call 516-341-0666
8:30am-4:30pm ET. Mon-Fri
Directions
take preferably at bedtime or as directed by a doctor
do not exceed maximum dosage
| age | starting dosage | maximum dosage |
| adults and children 12 years of age or older | 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 |
Package Label.Principal Display Panel
NDC 69618-064-01
Reliable-1 Laboratories®
Senna
Sennosides 8.6 mg
Natural Vegetable Laxative
100 Tablets
*Compare to the Active Ingredient in SENOKOT®
* Please review the disclaimer below.
