Senna
FDA Label NDC 45865-974

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medsource Pharmaceuticals for the product Senna (NDC 45865-974). 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

Active Ingredient (In Each Tablet)

Sennosides 8.6 mg

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
    • agestarting dosagemaximum dosage
    adults and children 12 years of age and older
    		2 tablets once a day
    		4 tablets twice a day
    children 6 to under 12 years of age
    		1 tablet once a day
    		2 tablets twice a day
    children 2 to under 6 years of age
    		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 20 mg
  • Store at room temperature
  • Do not use if imprinted seal under cap is broken or missing

Inactive Ingredients

Calcium carbonate, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium sulfate, stearic acid, triacetin.

Questions?

If you have any questions or comments,or to report an adverse event, please contact (800) 795-9775.

* Please review the disclaimer below.