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Drug Facts
Senna
FDA Label NDC 69618-048
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 69618-048). 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 ingredients (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 Ingredients (In Each Tablet)
Sennosides 8.6 mg
Purpose
Stimulant Laxative
Uses
- relieves occasional constipation (irregulatiry)
- generally causes bowel movement in 6-12 hours
Warnings
Do not use
- laxative 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 movements 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 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
- if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease does until you are comfortable
| Age | starting dosage | maximum dosage |
| adults children 12 years and over | 2 tablets once a day | 4 tablets twice a day |
| children 6 to under 12 years | 1 tablet once a day | 2 tabelts 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 25 mg, sodium 2 mg (VERY LOW SODIUM)
- store at 25°c (77°F) excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients
croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil
Questions Or Comments?
Call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday
Package Label.Principal Display Panel
NDC 69618-018-01
Reliable-1® LABORATORIES
Micro-Coated
Senna
Sennosides 8.6 mg
(standardized senna concentrate)
NATURAL VEGETABLE LAXATIVE
100 TABLETS
*Compare to the Active Ingredient in SENOKOT®
Senna (Senna)
* Please review the disclaimer below.
