Active Ingredient (In Each Tablet)
Sennosides 8.6 mg
Senna
FDA Label NDC 17714-122
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advance Pharmaceutical Inc. for the product Senna (NDC 17714-122). 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 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 Use 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
| a
ge | 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
|
Other Information
- each tablet contains: calcium 25 mg, sodium 2mg (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 631-981-4600, 8.30 am-4.30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Principal Display Panel
NDC: 17714-122-01
Senna 8.6mg
* Please review the disclaimer below.
